Moving the Frontiers of Cancer Chemotherapy for Solid Tumors by Changing the Scope of Drug Development

References

• Calabresi, P. and Chabner, A. (1990). The Pharmacological Basis of Therapeutics, edited by Goodman and Gilman's, Pergamon Press, 1201–1263.
   Google Scholar
• Judson, I., Clarke, S. and Ward, J., et al., (1992). Pharmacokinetics of ICI DD1694 following a 15 minute infusion in patients with advanced cancer. Proc. Am. Soc. Clin. Oncol., 11, 117.
   Google Scholar
• Cunningham, D., Zalcberg, J. and Francois, E., et al., (1994). Tomudex (ZD1694) a new thymidylate synthase inhibitor with good antitumor activity in advanced colorectal cancer. Proc. Am. Soc. Clin. Oncol., 13, 199.
   Google Scholar
• Zalcberg, J., Cunningham, D. and Rath, U., et al., (1995). Tomudex (ZD1694) has a higher response rate, significantly less leucopenia and mucositis and a simpler dosing regimen than 5-fluorouracil (5-FU) and leucovorin (LV) for advanced colorectal cancer: First results of a phase III study. Eur. J. Cancer, 31A, (suppl 5), S146.
   PubMedGoogle Scholar
• Tempero, M., Capadano, M. and Tarassoff, P., (1994). Dose escalation of gemcitabine in previously untreated patients with pancreatic adenocarcinoma [abstract], Proc. Am. Soc. Clin. Oncol., 13, 218.
   Google Scholar
• Richards, F., White, D. and Muss, H., et al. (1994). Phase I trial of gemcitabine over 30 minutes in patients with non-small cell lung cancer [abstract] Proc. Am. Soc. Clin. Oncol., 13, 344.
   Google Scholar
• Morgan-Ihrig, C., Lembersky, B. and Christopherson, W., et al., (1991). A phase II evaluation of difluorodeoxy-cytidine (dFsC) in advanced stage refractory ovarian cancer. Proc. Am. Soc. Clin. Oncol., 10, 196.
   Google Scholar
• Lund, B., Hansen, O. P. and Neijt, J. P., et al., (1992). Phase II study of Gemcitabine in previously treated ovarian cancer patients. Proc. Am. Soc. Clin. Oncol., 11, 222.
   Google Scholar
• Anderson, H., Lund, B. and Bach, F., et al. (1994). Single agent activity of weekly Gemcitabine in advanced non-small cell lung cancer: a phase II study. J. Clin. Oncol., 12, 1821–1826.
   PubMed Web of Science ®Google Scholar
• Negoro, S., Fukuoka, M. and Kurita, Y., et al., (1994). Results of phase II studies of Gemcitabine in non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol., 13, 367.
   Google Scholar
• Fossella, F. V., Lippman, S. M. and Tarassoff, P., et al. (1995). Phase I/II study of Gemcitabine, an active agent for advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol., 14, 371.
   Google Scholar
• Sheperd, F., (1993). Single agent efficacy of Gemcitabine in the treatment of lung cancer. In: Gemcitabine, novel combination of efficacy and tolerability. Proc. ECCO-7 Salellite Symposium, pp 12–13.
   Google Scholar
• Abratt, R. P., Bezwoda, W. R. and Falkson, G., et al., (1994). Efficacy and safety of Gemcitabine in non-small cell lung cancer: A phase II study. J. Clin. Oncol., 12, 1535–1540.
   PubMed Web of Science ®Google Scholar
• Begbie, S. D., Hui, R. and Levi, J. A., et al. (1995). Initial experience with Gemcitabine for non-small cell lung cancer in Australia. Proc. Am. Soc. Clin. Oncol., 14, 378.
   Google Scholar
• Gatzemeier, U., Sheperd, F. and Le Chevalier, T., et al. (1994). A multicenter phase III trial with Gemcitabine in non-small cell lung cancer. Lung Cancer, 11, (suppl. 1), 121.
   Google Scholar
• Peters, G. J., Bergman, A. M. and Veerman, G., et al. (1994). Synergism between cisplatin and gemcitabine in resistant A2780 human ovarian cancer cell lines is schedule dependent [abstract], Proc. Am. Assoc. Cancer Res., 35, 1950A.
   Google Scholar
• Braakhuis, B. J. M., Ruiz van Haperen, V. W. T. and Berman, A. M., et al. (1994). Preclinical in vivo evaluation of the combination of 2,3 difluorodeoxycytidine and cisplatin [abstract]. Ann. Oncol., 5 suppl. 5, 82.
   Google Scholar
• Cormier, Y., Shepherd, F. and Burkes, R., et al. (1994). Phase I study of gemcitabine and cisplatin for advanced non-small cell lung cancer [abstract]. Proc. Am. Soc. Clin. Oncol., 13, 1140.
   Google Scholar
• Dunlop, D. J., Cameron, C. and Dabouis, G., et al. (1994). Phase I/II study of cisplatin in combination with gemcitabine in non-small cell lung cancer [abstract] Ann. Oncol., 4 suppl., 8, 154.
   Google Scholar
• Steward, W. P., Dunlop, D. J. and Cameron, C., et al. (1995). Phase I/II study of cisplatin in combination with gemcitabine in non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol., 14, 351.
   Google Scholar
• Egorin, M. J., Van Echo, D. A. and Tipping, S. J., et al. (1984). Pharmacokinetics and dosage reduction of cisdiamine(l,l-cyclobutanedicarboxylato)platinum in patients with impaired renal function. Cancer Res. 44, 5432–5438.
   PubMed Web of Science ®Google Scholar
• Calvert, A. H., Newell, D. R. and Gumbrell, L. A., et al. (1989). Carboplatin Dosage: Prospective evaluation of a simple formula based on renal function. J. Clin. Oncol. 11,1748–1756.
   Google Scholar
• Ma, J., Verweij, J. and Kolker, H. J., et al. (1994). Pharmacokinetic-dynamic relationship of cisplatin in vitro. Simulation of an i.v. bolus, 3 hr and 20 hr infusion. Br. J. Cancer, 5, 858–862.
   Google Scholar
• Reed, E., Ostchega, Y. and Steinberg, S. M., et al. (1990). Evaluation of platinum-DNA adduct levels relative to known prognostic variables in a cohort of ovarian cancer patients. Cancer Res., 50, 2256–2260.
   PubMed Web of Science ®Google Scholar
• Reed, E., Ozols, R. F. and Tarone, R., et al. (1988). The measurement of cisplatin-DNA adduct level in testicular cancer patients. Carcinogenesis, 9, 1909–1911.
   PubMed Web of Science ®Google Scholar
• Schellens, J. H. M., Ma, J. and Planting, A. S. T., Adaptive intrapatient dose-escalation of CDDP. Proc. Am. Soc. Clin. Oncol., 15, 364.
   Google Scholar
• Ozols, R. F., Ostchega, Y. and Myers, C. E., et al. (1985). High-dose cisplatin in hypertonic saline in refractory ovarian cancer. J. Clin. Oncol., 9, 1246–1250.
   Google Scholar
• Kaye, S. B., Lewis, C. R. and Paul, J., et al. (1992). Randomised study of two doses of cisplatin with cyclophosphamide in epithelial ovarian cancer. Lancet, 340, 329–333.
   PubMed Web of Science ®Google Scholar
• Levin, L. and Hryniuk, W. M. (1987). Dose intensity analysis of chemotherapy regimens in ovarian carcinoma. J. Clin. Oncol., 5, 756–767.
   PubMed Web of Science ®Google Scholar
• Mangioni, C., Colombo, N. and Bonazzi, C., et al. (1989). Weekly cisplatin with tri-weekly epirubicin in relapsing epithelial ovarian cancer. Proc. Second, IGCS meeting, 69 [abstract].
   Google Scholar
• Canetta, R. M. and Carter, S. K. (1984). Developing new drugs for ovarian cancer: a challenging task in a changing reality. J. Cancer Res. Clin. Oncol., 107, 111–124.
   PubMed Web of Science ®Google Scholar
• Zanaboni, F., Scarfone, G. and Presti, M., et al. (1991). Salvage chemotherapy for ovarian cancer recurrence: weekly cisplatin in combination with epirubicin or etoposide. Gynecol. Oncol., 43, 24–28.
   PubMed Web of Science ®Google Scholar
• van der Burg, M. E. L., Logmans, A. and de Wit, R., et al., Six weeks of weekly high dose cisplatin and daily oral vepesid: A highly active regimen for ovarian cancer patients failing on or relapsing after conventional platinum containing combination chemotherapy. Proc. Am. Soc. Clin. Oncol., 15, 772.
   Google Scholar
• Wani, M. C., Taylor, H. L. and Wall, M. E., et al. (1971). Plant antitumour agents: VI. The isolation and structure of Taxol, a novel antileukemic and antitumour agent from Taxus brevifolia. J. Am. Chem. Soc., 93, 2325–2327.
   PubMed Web of Science ®Google Scholar
• Mangatal, L., Adeline, M. T. and Guenard, D., et al. (1989). Application of the vicinal oxymination reaction with asymmetric induction to the hemisynthesis of Taxol and analogues. Tetrahedron, 45, 4177–4190.
   Web of Science ®Google Scholar
• Webster, L., Linsenmeyer, M. and Millward, M., et al. (1993). Measurements of cremophor EL following Taxol: plasma levels sufficient to reverse drug exclusion mediated by the multidrug-resistant phenotype. J. Natl. Cancer Inst., 85, 1685–1690.
   PubMed Web of Science ®Google Scholar
• Schiff, P. B. and Horwitz, S. B. (1980). Taxol stabilizes microtubules in mouse fibroblast cells. Proc. Natl. Acad. Sci. USA, 77, 1561–1565.
   PubMed Web of Science ®Google Scholar
• Pamess, P. B. and Horwitz, S. B. (1981). Taxol binds to polymerized microtubules in vitro. J. Cell. Biol, 91, 470–487.
   Web of Science ®Google Scholar
• Manfredi, J. J. and Horwitz, S. B. (1984). Taxol: an antimitotic agent with a new mechanism of action. Pharmacol. Ther., 25, 83–125.
   PubMed Web of Science ®Google Scholar
• Correia, J. J. (1991). Effects of antimitotic agents on tubulin-nucleotide interactions. Pharmacol. Ther., 52, 127–147.
   PubMed Web of Science ®Google Scholar
• Edelman, G. (1976). Surface modulation in cell recognition and cell growth. Science, 192, 218–226.
   PubMed Web of Science ®Google Scholar
• Dustin, P. (1980). Microtubules. Sci. Am., 243, 66–76.
   PubMedGoogle Scholar
• Crossin, K. L. and Carney, D. H. (1981). Evidence that microtubule depolymerisation early in the cell cycle is sufficient to initiate DNA synthesis. Cell, 23, 61–71.
   PubMed Web of Science ®Google Scholar
• Otto, A. M., Ulrich, M. O. and Zumbe, A., et al. (1981). Cytoskeletal-disrupting drugs enhance effect of growth factors and hormones on initiation of DNA synthesis. Proc. Natl. Acad. Sci. USA, 76, 6435–6438.
   Web of Science ®Google Scholar
• Rowinsky, E. K., Cazenave, L. A. and Donehower, R. C. (1990). Taxol: a novel investigational antimicrotubule agent. J. Natl. Cancer Inst., 82, 1247–1259.
   PubMed Web of Science ®Google Scholar
• Rowinsky, E. K., Donehower, R. C. (1991). The clinical pharmacology and use of antimicrotubule agents in cancer chemotherapeutics. Pharmacol. Ther., 52, 35–84.
   PubMed Web of Science ®Google Scholar
• Horwitz, S. B. (1992). Mechanism of action of Taxol. Trends Pharmacol. Sci., 13, 134–136.
   PubMed Web of Science ®Google Scholar
• Gueritte-Voegelein, F., Guenard, D., Lavelle, F., et al. (1991). Relationships between the structure of Taxol analogues and their antimitotic activity. J. Med. Chem., 34, 992–998.
   PubMed Web of Science ®Google Scholar
• Verweij, J., Clavel, M., Chevalier, B. (1994). Paclitaxel (Taxol) and docetaxel (Taxotere): not simply two of a kind. Ann. Oncol., 5, 495–505.
   PubMed Web of Science ®Google Scholar
• Riou, J. F., Naudin, A., Lavelle, F. (1992). Effects of taxotere on murine and human tumor cell lines. Biochem. Biophys. Res. Comm., 187, 164–170.
   PubMed Web of Science ®Google Scholar
• Kelland, L. R., Abel, G. (1992). Comparative in vitro cytotoxicity of Taxol and Taxotere against cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Cancer Chem. Phar., 30, 444–450.
   PubMed Web of Science ®Google Scholar
• Hanauske, A., Degen, D., Hilsenbeck, S. G., et al. (1992). Effects of Taxotere and Taxol on in vitro colony formation of freshly explanted human tumor cells. Anticancer Drugs, 3, 121–124.
   PubMed Web of Science ®Google Scholar
• Vogel, M., Hilsenbeck, S. G., Depenbrock, H., et al. (1993). Preclinical activity of Taxotere (RP 56976, NSC 628503) against freshly explanted clonogenic human tumour cells: comparison with Taxol and conventional antineoplastic agents. Eur. J. Cancer, 29A, 2009–2014.
   PubMed Web of Science ®Google Scholar
• Bissery, M. C., Guenard, D., Gueritte-Voegelein, F., et al. (1991). Experimental antitumor activity of Taxotere (RP 56976, NSC 628503), a Taxol analogue. Cancer Res., 51, 4845–4852.
   PubMed Web of Science ®Google Scholar
• Rowinsky, E. K., Gilbert, M. R., McGuire, W. P., et al. (1991). Sequences of Taxol and cisplatin: a phase I pharmacologic study. J. Clin. Oncol., 9, 1692–1703.
   PubMed Web of Science ®Google Scholar
• Rowinsky, E. K., Chaudry, V., Forastiere, A., et al. (1993). Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J. Clin. Oncol., 11, 2010–2020.
   PubMed Web of Science ®Google Scholar
• Gehl, J., Ejlersen, B., Boesgaard, M. et al. (1994). Efficacy and toxicity of combined doxorubicin and paclitaxel in metastatic breast cancer (preliminary results) [ab-stract] Ann. Oncol., 5 Suppl. 8, 99.
   Google Scholar
• Eisenhauer, E. A., Ten Bokkel Huinink, W. W., Swenerton, K. D., et al. (1994). European-Canadian randomised trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J. Clin. Oncol., 12, 2654–2666.
   PubMed Web of Science ®Google Scholar
• Markman, M., Hakes, T., Reichman, B., et al. (1993). Memorial Sloan-Kettering Cancer Center experience with National Cancer Institute Treatment referral center protocol 9103: Taxol in refractory ovarian cancer [abstract]. Proc. Am. Soc. Clin. Oncol., 12, 266.
   Google Scholar
• Trimble, E. L., Adams, J. D., Vena, D., et al. (1993). Paclitaxel for platinum-refractory ovarian cancer: results from the first 1000 patients registered to National Cancer Institute Treatment Referral Center 9103. J. Clin. Oncol., 11, 2405–2410.
   PubMed Web of Science ®Google Scholar
• Thigpen, J. T., Blessing, J. A., Ball, H., et al. (1994). Phase II trial of paclitaxel in patients with progressive ovarian carcinoma after platinum-based chemotherapy: a Gynecologic Oncology Group study. J. Clin. Oncol., 12, 1748–1753.
   PubMed Web of Science ®Google Scholar
• McGuire, W. P., Rowinsky, E. K., Rosenheim, N. B., et al. (1989). Taxol: an unique antineoplastic agent with significant activity in advanced ovarian epithelial neoplasms. Ann. Int. Med., 111, 273–279.
   PubMed Web of Science ®Google Scholar
• Einzig, A. E., Wiemik, P. H., Sasloff, J., et al. (1992). Phase II study and long-term follow-up of patients treated with Taxol for advanced ovarian adenocarcinoma. J. Clin. Oncol., 10, 1748–1753.
   PubMed Web of Science ®Google Scholar
• Kavanagh, J. J., Kudelka, A. P., Edwards, C. L., et al. (1993). A randomized crossover trial of parenteral hydroxurea vs high dose Taxol in cisplatin/carboplatin resistant epithelial ovarian cancer [abstract]. Proc. Am. Soc. Clin. Oncol., 12, 259.
   Google Scholar
• Uziely, B., Groshen, S., Jeffers, S., et al. (1994). Paclitaxel in heavily pretreated ovarian cancer: antitumor activity and complications. Ann. Oncol., 5, 827–833.
   PubMed Web of Science ®Google Scholar
• Aravantinos, G., Skarlos, D., Kosmidis, P., et al. (1994). Taxol in platinum pretreated ovarian cancer patients (preliminary results) [abstract] Ann. Oncol., 5 Suppl. 8, 102.
   Google Scholar
• McGuire, W. P., Hoskins, W. J. and Brady, M. F., et al. (1995). Taxol and cisplatin improves outcome in advanced ovarian cancer as compared to cytoxan and cisplatin [abstract]. Proc. Am. Soc. Clin. Oncol., 14, 275.
   Google Scholar
• Holmes, F. A., Walters, R. S. and Theriault, R. L., et al. (1991). Phase II trial of Taxol, an active drug in the treatment of metastatic breast cancer. J. Natl. Cancer Inst., 83, 1797–1805.
   PubMed Web of Science ®Google Scholar
• Reichman, B. S., Seidman, A. D. and Crown, J. P. A., et al. (1993). Paclitaxel and recombinant human granulocyte colony-stimulating factor as initial therapy for metastatic breast cancer. J. Clin. Oncol., 11, 1943–1951.
   PubMed Web of Science ®Google Scholar
• Nabholtz, J. M., Gelmon, K. and Bontenbal, M., et al. (1991). Randomised trial of two doses of Taxol in metastatic breast cancer: an interim analysis [abstract], Proc. Am. Soc. Clin. Oncol., 12, 60.
   Google Scholar
• Fumoleau, P., Chevallier, B. and Dieras, V., et al. (1994). Evaluation of two doses of Taxotere (docetaxel) as first line in advanced breast cancer—EORTC Clinical Screening Group report [abstract], Ann. Oncol., 5 Suppl. 8.
   PubMedGoogle Scholar
• Abrams, J. S., Vena, D. A. and Baltz, J., et al. (1994). Paclitaxel (taxol) activity in heavily treated metastatic breast cancer [abstract], Ann. Oncol., 5 Suppl. 5, 199.
   PubMedGoogle Scholar
• Holmes, F. A., Valero, V. and Theriault, R., et al. (1993). Phase II trial of Taxol in metastatic breast cancer refractory to multiple prior treatments [abstract], Proc. Am. Soc. Clin. Oncol., 12, 91.
   Google Scholar
• Pober, M., Bauemhofer, Th. and Samonigg, H., et al. (1994). Paclitaxel in extensively pretreated patients with advanced breast cancer [abstract], Ann. Oncol., 5 Suppl. 8, 35.
   PubMedGoogle Scholar
• Seidman, A., Crown, J. and Reichman, B., et al. (1993). Lack of clinical cross-resistance of Taxol with anthracy-cline in the treatment of metastatic breast cancer [abstract] Proc. Am. Soc. Clin. Oncol., 12, 63.
   Google Scholar
• Verweij, J., Planting, A. S. T. and Van der Burg, M. E. L., et al. (1994). A phase I study of docetaxel and cisplatin in patients with solid tumors. Ann. Oncol., 5 Suppl. 8, 180.
   Google Scholar
• Zalcberg, J., Bishop, J. F. and Webster, L. K., et al. (1994). A phase I trial of the combination taxotere (docetaxel) and cisplatin in patients with advanced non-small cell lung cancer. Ann. Oncol., 5 Suppl. 8, 154.
   Google Scholar
• Klastersky, J., Sculier, J. P. and Mommen, P., et al. (1994). Paclitaxel plus cisplatin in stage IV non-small cell lung cancer: A dose finding study. Ann. Oncol., 5 Suppl. 8, 154.
   Google Scholar
• Schellens, J. H. M., Ma, J. and Planting, A. S. T., et al. (1994). Pharmacokinetics and WBC DNA-adduct formation of cisplatin in the sequence docetaxel/cisplatin and cisplatin/docetaxel in a phase I/II study in solid tumor patients. Ann. Oncol., 5 Suppl. 5, 201.
   Google Scholar
• Aapro, M. S., Pujade-Lauraine, E. and Lhommé, C., et al. (1994). EORTC Clinical Screening Group: Phase II study of Taxotere in ovarian cancer. Ann. Oncol., 5 Suppl. 5, 202.
   Google Scholar
• Piccart, M. J., Gore, M. and Ten Bokkel Huinink, W. W., et al. (1994). Final results of a large phase II clinical trial of docetaxel (Taxotere, RP 56976) in advanced ovarian cancer patients failing platinum. Ann. Oncol., 5 Suppl. 8, 99.
   Google Scholar
• Kavanagh, J. J., Kudelka, A. P. and Freedman, R. S., et al. (1993). A phase II trial of Taxotere in ovarian cancer patients refractory to cisplatin/carboplatin therapy. Proc. Am. Soc. Clin. Oncol., 12, 259.
   Google Scholar
• Francis, P., Schneider, J. and Hann, L., et al. (1994). Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J. Clin. Oncol., 12, 2301–2308.
   PubMed Web of Science ®Google Scholar
• Fumoleau, P., Chevallier, B. and Dieras, V., et al. (1994). Evaluation of two doses of Taxotere (docetaxel) as first line in advanced breast cancer—EORTC Clinical Screening Group Report. Ann. Oncol., 5 Suppl. 8.
   PubMedGoogle Scholar
• Seidman, A. D., Hudis, C. and Crown, J. P. A., et al. (1993). Phase II evaluation of taxotere as initial chemotherapy for metastatic breast cancer. Proc. Am. Soc. Clin. Oncol., 12, 63.
   Google Scholar
• Trudeau, M., Eisenhauer, E. and Lofters, W., et al. (1993). Phase II study of taxotere as first line chemotherapy for metastatic breast cancer: A National Cancer Institute of Canada Clinical Trials Group study. Proc. Am. Soc. Clin. Oncol., 12, 64.
   Google Scholar
• Ten Bokkel Huinink, W. W., Prove, A. M. and Piccart, M., et al. (1994). A phase II trial with Docetaxel (Taxotere) in second line treatment with chemotherapy for metastatic breast cancer. Ann. Oncol., 5, 527–532.
   PubMed Web of Science ®Google Scholar
• Valero, V., Ravdin, P. M. and Walters, R., et al. (1994). Taxotere (docetaxel) in the treatment of anthracyclin/anthracenedione-refractory metastatic breast cancer: combined results of 2 U.S. phase II studies. Ann. Oncol., 5 Suppl. 8, 33.
   Google Scholar
• Kerbrat, P, Chevallier, B., Dieras, V., et al. (1994). Activity of Taxotere (docetaxel) in liver metastasis of advanced breast cancer: Analysis on 17 patients. Experience of the EORTC Clinical Screening Cooperative Group. Ann. Oncol., 5 Suppl. 8, 32.
   Google Scholar
• Valera, V., Walters, R., Theriault, R., et al. (1994). Phase II study of docetaxel (taxotere) in anthracycline-refractory metastatic breast cancer. Proc. Am. Soc. Clin. Oncol., 13, 470.
   Google Scholar
• Murphy, W. K., Fossela, F. V., Winn, R. J., et al. (1993). Phase II study of taxol in patients with untreated advanced non-small cell lung cancer. J. Natl. Cancer Inst., 85, 384–388.
   PubMed Web of Science ®Google Scholar
• Chang, A. Y., Kim, K., Glick, J., et al. (1993). Phase II study of taxol, merbarone, and piroxantrone in stage IV non-small lung cancer: the Eastern Cooperative Oncology Group results. J. Natl. Cancer Inst., 85, 388–394.
   PubMed Web of Science ®Google Scholar
• van Pawel, J., Wagener, H., Gatzemeier, U., et al. (1994). Phase II study with paclitaxel (Taxol) in advanced inoperable non-small cell lung cancer. Ann. Oncol., 5 Suppl. 8, 155.
   PubMedGoogle Scholar
• Cerny, T., Kaplan, S., Pavlidis, N., et al. (1994). Docetaxel (taxotere) is active in non-small lung cancer: A phase II trial of the EORTC Early Clinical Trials Group. Br. J. Cancer. 70, 384–387.
   PubMed Web of Science ®Google Scholar
• Fossella, F. V., Rigas, J. R., Burris, H. A., (1994). Taxotere (docetaxel) for previously untreated advanced non-small cell lung cancer: combined results of 3 U.S. phase II trials. Ann. Oncol., 5 Suppl. 8, 156.
   Google Scholar
• Kawahara, M., Furuse, K., Watanabe, K., et al. (1994). Phase II studies of docetaxel in patients with non-small cell lung cancer. Ann. Oncol., 5 Suppl. 8, 148.
   Google Scholar
• Fosselle, F. V., Burris, H. A. (1994). Taxotere (docetaxel) for advanced non-small cell lung cancer previously treated with platinum: combined results of 2 U.S. phase II trials. Ann. Oncol., 5 Suppl. 8, 156.
   Google Scholar
• Forastiere, A. A., Neuberg, D., Taylor, S. G., et al. (1993). Phase II evaluation of Taxol in advanced head and neck cancer: An Eastern Cooperative Oncology Group trial. Proc. Am. Soc. Clin. Oncol., 12, 277.
   Google Scholar
• Catimel, G., Verweij, J., Mattijsen, V., et al. (1994). Docetaxel (Taxotere): An active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. Ann. Oncol., 5, 533–537.
   PubMed Web of Science ®Google Scholar
• Gottlieb, J. A., Guarino, A. M., Call, J. B., et al. (1970). Preliminary pharmacologic and clinical evaluation of camptothecin sodium (NSC 100880). Cancer Chemother. Rep., 54, 461–470.
   PubMedGoogle Scholar
• Muggia, F. M., Creaven, P. J., Hansen, H. H., et al. (1972). Phase I clinical trial of weekly and daily treatment with camptothecin (NSC 100880): Correlation with preclinical studies. Cancer Chemother. Rep., 56, 515–521.
   PubMedGoogle Scholar
• Moertel, C. C. G., Schutt, A. J., Reitemeier, et al. (1972). Phase II study of camptothecin (NSC 100880) in the treatment of advanced gastrointestinal cancer. Cancer Chemother. Rep., 56, 95–101.
   PubMedGoogle Scholar
• Creaven, P. J., Allen, L. M., Muggia, F. M. (1972). Plasma camptothecin (NSC 100880) levels during a 5-days course of treatment: relation to dose and toxicity. Cancer Chemother. Rep., 56, 573–578.
   PubMedGoogle Scholar
• Hsiang, Y. H., Liu, L. F. (1988). Identification of mammalian DNA topoisomerase I as an intracellular target of the anticancer drug Camptothecin. Cancer Res., 48, 1722–1726.
   PubMed Web of Science ®Google Scholar
• Schmitt, B., Bukre, U., Vosberg, H. P. (1984). Characterisation of size variant of type I DNA topoisomerase is isolated from calf thymus. Eur. J. Biochem., 144, 127–134.
   PubMedGoogle Scholar
• D'Arpa, P. Machlin, P. S., Ratrie, H., et al. (1988). cDNA cloning of human DNA topoisomerase I: Catalytic activity at 67.7 kDa carboxyl-terminal fragment. Proc. Natl Acad. Sci. USA, 85, 2543–2547.
   PubMed Web of Science ®Google Scholar
• Creemers, G. J., Lund, B., Verweij, J. (1994). Topoisomerase I inhibitors: topotecan and irinotecan. Cancer Treat. Rev., 20, 73–96.
   PubMed Web of Science ®Google Scholar
• Hsiang, Y. H., Likou, M. G., Liu, L. F. (1989). Arrest of replication forks by drug stabilized topoisomerase-I-DNA cleavable complexes as a mechanism of cell killing by camptothecin. Cancer Res., 49, 5077–5082.
   PubMed Web of Science ®Google Scholar
• Burris, H. A., Hanauske, A. R., Johnson, R. K., et al. (1992). Activity of topotecan a new topoisomerase I inhibitor, against human tumor colony-forming units in vitro. J. Natl Cancer Inst., 84, 1816–1820.
   PubMed Web of Science ®Google Scholar
• Potmesil, M. (1994). Camptothecins: from bench research to hospital wards. Cancer Res., 54, 1431–1439.
   PubMed Web of Science ®Google Scholar
• McLeod, H. L., Douglas, F. and Oates, M., et al. (1994). Topoisomerase I and II activity in human breast, cervix, lung and colon cancer. Int. J. Cancer, 59, 607–611.
   PubMed Web of Science ®Google Scholar
• Van der Zee, A. G. J., de Jong, S. and Keith, W. N., et al. (1994). Quantitative and qualitative aspects of topoisomerase I and IIα and β in untreated and platinum/cyclophosphamide treated malignant ovarian tumors. Cancer Res., 54, 749–755.
   PubMed Web of Science ®Google Scholar
• Giovanella, B. C., Stehlin, J. S. and Wall, M. E., et al. (1989). DNA-topoisomerase I targeted chemotherapy of human colon cancer in xenografts. Science, 246, 1046–1048.
   PubMed Web of Science ®Google Scholar
• Kawato, J., Aonuma, M. and Hiroto, Y., et al. (1991). Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11. Cancer Res., 51, 4187–4191.
   PubMed Web of Science ®Google Scholar
• Kanzawa, F., Sugimoto, Y. and Minato, K., et al. (1990). Establishment of a camptothecin analogue (CPT-11)-resistant cell line of human non-small cell lung cancer: characterisation and mechanism of resistance. Cancer Res., 50, 5919–5924.
   PubMed Web of Science ®Google Scholar
• Von Hoff, D. D., Burris III, H. A. and Eckardt, J., et al. (1994). Preclinical and phase I trials of topoisomerase I inhibitors. Cancer Chemother. Pharmocol., 34 Suppl.: S41–45.
   PubMedGoogle Scholar
• Mitsui, I., Kumazawa, E. and Hirota, Y., et al. (1993). Antitumor activity of DX8951, a new camptothecin derivative [abstract]. Proc. Am. Assoc. Cancer Res., 34, 421.
   Google Scholar
• Rothenberg, M. L., Kuhn, J. and Burris, H. A., et al. (1992). CPT-11: phase I experience using a weekly schedule [abstract]. Ann. Oncol., 3 Suppl. 1, 119.
   Google Scholar
• Rothenberg, M. L., Kuhn, J. and Burris, H. A., et al. (1992). A phase I and pharmacokinetic trial of CPT-11 in patients with refractory solid tumors [abstract]. Proc. Am. Soc. Clin. Oncol., 11, 113.
   Web of Science ®Google Scholar
• Rowinsky, E., Grochow, L. and Ettinger, D., et al. (1992). Phase I and pharmacologic study of CPT-11, a semisynthetic topoisomerase I-targeting agent on a single dose schedule [abstract]. Proc. Am. Soc. Clin. Oncol., 11, 115.
   Google Scholar
• Negoro, S., Fukuoka, M. and Masuda, N., et al. (1991). Phase I study of weekly intravenous infusion of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small cell lung cancer. J. Natl. Cancer Inst., 83, 1164–1168.
   PubMed Web of Science ®Google Scholar
• Ohe, I., Sasaki, Y. and Shinkai, T., et al. (1992). Phase I study and pharmacokinetics of CPT-11 with 5-day continuous infusion J. Natl. Cancer Inst., 84, 972–974.
   PubMed Web of Science ®Google Scholar
• Culine, S., De Forni, M. and Extra, J. M., et al. (1992). Phase I study of the camptothecin analogue CPT-11, using a weekly schedule [abstract]. Proc. Am. Soc. Clin. Oncol., 11, 110.
   Google Scholar
• Clavel, M., Chabot, G. and Dumortier, A., et al. (1992). Phase I study of the camptothecin analog CPT-11, administered daily for 3 consecutive days [abstract]. Ann. Oncol., 3 Suppl. 1, 83.
   Google Scholar
• Gandia, D., Armand, J. P. and Chabot, G. G. (1992). Phase I study of the new camptothecin analogue CPT-11 administered every 3 weeks [abstract] Proc. Am. Assoc. Cancer Res., 33, 260.
   Google Scholar
• Abigerges, D., Armand, J. P. and Chabot, G. G. (1993). High dose intensity of CPT-11 administered as a single dose every 3 weeks: the Institute Gustave Roussy experience [abstract] Proc. Am Soc. Clin. Oncol., 12, 133.
   Google Scholar
• Extra, J. M., Rougier, Ph. and Ychou, M., et al. (1995). A phase II study of CPT-11 (Irinotecan) in refractory to 5FU colorectal cancer with preventive treatment of delayed diarrhea by acetorphan. Eur. J. Cancer, 31A Suppl. 5, S152.
   PubMedGoogle Scholar
• Rowinsky, E. K., Grochow, L. B. and Ettinger, D. S., et al. (1994). Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-[4-(1-piperidino)-1-piperidino] carbonyloxycamptothecin (CPT-11) administered as a ninety-minute infusion every 3 weeks. Cancer Res., 54, 427–436.
   PubMed Web of Science ®Google Scholar
• Shimada, Y., Yoshino, M. and Wakui, A., et al. (1991). Phase II study of CPT-11, a new camptothecin derivative, in patients with metastatic colorectal cancer [abstract] Proc. Am. Soc. Clin. Oncol., 10, 135.
   Google Scholar
• Rougier, P., Bugat, R. and Douillard, J. Y., et al. (1994). Irinotecan (CPT-11) as first line therapy in advanced colorectal cancer: preliminary results of a multicentric phase II study. Ann. Oncol. 5 Suppl. 8,188.
   Google Scholar
• Conti, J. A., Kemeny, N. and Saltz, L., et al. (1994). Irinotecan (CPT-11) is an active agent in untreated petiemts with metastatic colorectal cancer. Proc. Am. Soc. Clin. Oncol., 13, 195.
   Google Scholar
• Pitot, H. C., Wender, D. and O'Connell, M. J., et al. (1994), A phase II trial of CPT-11 (irinotecan) in patients with metastatic colorectal carcinoma: a North Central Cancer Treatment Group study. Proc. Am. Soc. Clin. Oncol., 13, 197.
   Google Scholar
• Rothenberg, M. L., Eckhardt, J. R. and Burris, H. A., et al. (1994). Irinotecan (CPT-11) as second-line therapy for patients with 5FU refractory colorectal cancer. Proc. Am. Soc. Clin. Oncol., 13, 198.
   Google Scholar
• Bugat, R., Rougier, P. and Becoum, Y., et al. (1994). Irinotecan (CPT-11) is an effective agent in pretreated colorectal cancer: preliminary results of a multicentre phase II study. Ann. Oncol., 5 Suppl. 8, 188.
   Google Scholar
• Kano, Y., Suzuki, K. and Akutsu, M., et al. (1992). Effects of CPT-11 in combination with other anti-cancer agents in culture. Int. J. Cancer, 50, 604–610.
   PubMed Web of Science ®Google Scholar
• Mattem, M. R., Hofmann, G. A. and McCabe, F. L., et al. (1991). Synergistic cell killing by ionizing radiation and topoisomerase I inhibitor topotecan (SK&F 104864). Cancer Res., 51, 5813–5816.
   PubMed Web of Science ®Google Scholar
• Masuda, N., Fukuoka, M. and Takada, et al. (1992). CPT-11 in combination with cisplatin for advanced non-small cell lung cancer. J. Clin. Oncol., 10, 1775–1780.
   PubMed Web of Science ®Google Scholar
• Hsiang, Y. H., Hertzberg, R., Hecut, S. and Liu, L. F. (1985). Camptothecin induces protein-limited DNA breaks via mammalian DNA topoisomerase I. J. Biol. Chem., 260, 14873–14878.
   PubMed Web of Science ®Google Scholar
• Ardizzoni, A., Hansen, H. H. and Dombemowsky, P., et al. (1995). Phase II study of topotecan in refractory and sensitive small cell lung cancer. Eur. J. Cancer, 31A Suppl. 5, S19.
   PubMedGoogle Scholar
• Verweij, J., (1995). Topotecan, a review on a clinically active new anticancer agent. Proc. 6th Conference of DNA topoisomerases in therapy, p S66.
   Google Scholar
• Carmichael, J., Gordon, A. and Malfetano, J., et al. (1996). Topotecan, a new active drug, vs paclitaxel in advanced epithelial ovarian carcinoma: International Topotecan Study Group Trial. Proc. Am. Soc. Clin. Oncol., 15, 765.
   Google Scholar
• Creemers, G. J., Schellens, J. H. M. and Beynen, J. H. et al. (1994). Bioavailability of oral topotecan, a new topoisomerase I inhibitor. Proc. Am. Soc. Clin. Oncol., 13, 132.
   Google Scholar
• Schellens, J. H. M., Eckhardt, J. R. and von Hoff, D. D., et al. (1995). Pharmokinetics, clinical pharmacodynamics and safety of chronic oral topotecan in a phase I study. Eur. J. Cancer, 31A suppl. 5, S192.
   Google Scholar
• Rowinsky, E., Grochow, L. and Kaufmann, S., et al. (1994). Sequence-dependent effects of topotecan and cisplatin in a phase I and pharmacokinetic study [abstract], Proc. Am. Soc. Clin. Oncol., 13, 142.
   Google Scholar
• Cohen, P. and Honslay, M. (eds.) (1985). Molecular mechanisms of transmembrane signalling, molecular aspects of cellular regulation. Elsevier Publishers, New York.
   Google Scholar
• Rozengurt, E. (1986). Early signals in the mitogenic response. Science, 234, 161–166.
   PubMed Web of Science ®Google Scholar
• Munder, P. G., Weltzein, H. U. and Modolell, M. (1977). Lysolecithin analogs: a new class of immunopotentiators. In: Miescher, P. A., editor. VII International Symposium on Immunopathology. Basel: Schwabe Pub.: 411–413.
   Google Scholar
• Pronk, L. C., Planting, A. S. T. and Oosterom, R., et al. (1994). Increases in leucocyte and platelet counts induced by the alkyl phospholipid hexadecylphosphocholine. Eur. J. Cancer, 30A, 1019–1022.
   PubMed Web of Science ®Google Scholar
• Berdel, W. E., (1990). Ether lipids and derivatives as investigational anticancer drugs. A brief review. Onkologie, 13, 245–250.
   PubMedGoogle Scholar
• Powis, G. (1991). Signalling targets for anticancer drug development. Trends Pharmocol. Sci., 12, 188–194.
   PubMed Web of Science ®Google Scholar
• Storme, G. A., Berdel, W. E. and van Blitterswijk, W. J., et al. (1985). Antiinvasive effect of racemic 1-O-octadecyl-2-O-methyl-glycero-3-phosphocholine on MO4 mouse fibrosarcoma cells in vitro. Cancer Res., 45, 351–357.
   PubMed Web of Science ®Google Scholar
• Workman, P. (1991). The cell membrane and cell signals: New targets for novel anticancer drugs. Ann. Oncol., 1, 100–111.
   Web of Science ®Google Scholar
• Khayat, D., Clavel, M. and Gad-El-Mawla, N., et al. (1994). Miltefosine topical treatment of skin-metastatic breast cancer: overview analysis of clinical phase II trial data. Annals Oncol., 5 suppl. 8, P163.
   PubMedGoogle Scholar
• Nishizuka, Y. (1988). The molecular heterogenity of protein kinase C and its implication for cellular regulation. Nature, 334,661–665.
   PubMed Web of Science ®Google Scholar
• Schwartz, G. K., Jiang, J. and Kelse, D., et al. (1993). Protein kinase C: a novel target for inhibiting gastric cancer cell invasion. J. Natl. Cancer Inst., 85, 402–407.
   PubMed Web of Science ®Google Scholar
• Dumont, J. A., Jones Jr., D. and Bitonti, A. (1992). Inhibition of experimental metastasis and cell adhesion of B16F1 melanoma cells by inhibitors of protein kinase C. Cancer Res., 52, 1195–1200.
   PubMed Web of Science ®Google Scholar
• Lee, S. A. and Karaszkiewicz, Anderson, W. B., (1992). Elevated level of nuclear protein kinase C in multidrugresistant MCF-7 human breast carcinoma cells. Cancer Res., 52, 3750–3759.
   PubMed Web of Science ®Google Scholar
• Pettit, G. R. (1991). Bryostatins. In: Herz, W., Kirby, G. W., Steglich, W. and Tamm, C. (eds.) Progress in the chemistry of organic natural products. Springer-Verlag, New York. 154–195.
   Google Scholar
• Gescher, A. (1992). Towards selective pharmacological modulation of protein kinase C: opportunities for the development of novel antineoplastic agents. Br. J. Cancer, 66, 10–19.
   PubMed Web of Science ®Google Scholar
• Philip, P., Rea, D. and Balkwill, F., et al. (1993). Phase I trial of bryostatin-1: influence on the plasma concentrations of interleukin-6 and tumour necrosis factor-α [abstract]. Proc. Am. Assoc. Cancer Res., 34, 411.
   Google Scholar
• Helene, C. and Toulme, J. J. (1990). Specific regulation of gene expression by antisense, sense and antigene nucleic acids. Biochem. Biophys. Acta., 1049, 99–125.
   PubMed Web of Science ®Google Scholar
• Rothenberg, M., Johnson, G. and Laughlin, C., et al. (1989). Oligodeoxynucleotides as antisense inhibitors of gene expression: Therapeutic implications. J. Natl. Cancer Inst., 81, 1539–1544.
   PubMedGoogle Scholar
• Bishop, M. R., Iversen, P. L. and Bayever, E., et al. (1996). Phase I trial of an antisense oligonucleotide OL(1)p53 in hematologic malignancies J. Clin. Oncol., 14, 1320–1326.
   PubMed Web of Science ®Google Scholar
• Rak, J. W., St. Croix, B. D. and Kerbel, R. S. (1995). Consequences of angiogenesis for tumor progression, metastasis and cancer therapy. Anti-cancer Drugs, 6, 3–18.
   PubMed Web of Science ®Google Scholar