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Original Article

Phase I Study of Doxil® and Vinorelbine in Patients with Advanced Malignancies

, M.D., , M.D., , M.D., , M.D., &
Pages 344-352 | Published online: 18 Aug 2004

References

  • Gabizon A., Catane R., Uziely B., Kaufman B., Safra T., Cohen R., Martin F., Huang A., Barenholz Y. Prolonged circulation time and enhanced accumulation in malignant exudates of doxorubicin encapsulated in polyethylene-glycol coated liposomes. Cancer Res. 1994; 54: 987–992, [PUBMED], [INFOTRIEVE]
  • Northfelt D., Dezube B., Thommes J., Levine R., Von Roenn J., Dosik G., Rios A., Krown S., DuMond C., Mamelok R. Efficacy of pegylated liposomal doxorubicin in the treatment of AIDS-related Kaposi's sarcoma after failure of standard chemotherapy. J. Clin. Oncol. 1996; 15: 653–659
  • Northfelt D., Dezube B., Thommes J., Miller B., Fishcl M., Friedman-Kien A., Kaplan L., DuMond C., Mamelok R., Henry D. Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma: results of a randomized phase III clinical trial. J. Clin. Oncol. 1998; 16: 2445–2451, [PUBMED], [INFOTRIEVE]
  • Harrison M., Tomlinson N., Stewart S. Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma. J. Clin. Oncol. 1995; 13(4)914–920, [PUBMED], [INFOTRIEVE]
  • Stewart S., Jablonowski H., Goebel F., Arasteh K., Spittle M., Rios A., Aboulafia D., Galleshaw J., Dezube B. Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. J. Clin. Oncol. 1998; 16: 683–691, [PUBMED], [INFOTRIEVE]
  • Bergin C. Treatment of Kaposi's sarcoma with liposomal doxorubicin. Am. J. Health-Syst. Pharm. 1995; 52: 2001–2004
  • Muggia F., Hainsworth J., Jeffers S., Miller P., Groshen S., Tan M., Roman L., Uziely B., Muderspach L., Garcia A., Burnett A., Greco F., Morrow C., Paradiso L., Liang L. Phase II study of DOXIL in refractory ovarian cancer: antitumor activity and toxicity modification by liposomal encapsulation. J. Clin. Oncol. 1997; 15: 987–993, [PUBMED], [INFOTRIEVE]
  • Ranson M., Carmichael J., O'Byrne K., Stewart S., Smith D., Howell A. Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial. J. Clin. Oncol. 1997; 15: 3185–3191, [PUBMED], [INFOTRIEVE]
  • Working P., Newman M., Huang S., Mayhew E., Vaage J., Lasic D. Pharmacokinetics, biodistribution and therapeutic efficacy of doxorubicin encapsulated in Stealth® liposomes (Doxil®). J. Liposome Res. 1994; 4(1)667–687
  • Gordon K., Tajuddin A., Guitart J., Kuzel T., Eramo L., Roenn J. Hand-foot syndrome associated with liposome-encapsulated doxorubicin therapy. Cancer 1995; 75: 2169–2173, [PUBMED], [INFOTRIEVE]
  • Ranson M., O'Byrne K., Carmichael J., Smith D., Stewart S., Howell A. Phase II Dose-Finding Trial of Dox-SL® (Stealth® Liposomal Doxorubicin HCl) in the Treatment of Advanced Breast Cancer. ASCO. 1996; 161
  • Uziely B., Jeffers S., Isacson R., Kutsch K., WeiTsao D., Yehoshua Z., Libson E., Muggia F., Gabizon A. Liposomal doxorubicin: antitumor activity and unique toxicities during two complementary phase I studies. J. Clin. Oncol. 1995; 13(7)1777–1785, [PUBMED], [INFOTRIEVE]
  • Amantea M., Newman M., Sullivan T. Relationship of dose intensity to the induction of palmar-plantar erythrodysesthesia by pegylated liposomal doxorubicin in dogs. Hum. Exp. Toxicol. 1999; 18(1)17–26, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
  • Vaage J., Colbern G., Working P. Combined Antitumor Therapy with Doxil(R) and Navelbine in HT29 Colon Xenografts. ASCO. 1998; 977
  • Hoheneker J. A summary of vinorelbine (Navelbine) safety data from North American clinical trials. Semin. Oncol. 1994; 21: 42–47
  • Budman D., Calabro A., Wang L., Liu X., Stiel L., Kreis W., Adams L. Sequence dependent synergistic cytotoxic effects in vitro with vinorelbine and paclitaxel. Proc. AACR 1998; 39: 309, abstr # 2112
  • Krikorian A. Pharmacokinetics and metabolism of navelbine ®. Semin. Oncol. 1989; 16 (2)(Supplement 4)21–25
  • Havlin K., Lucas S., Guaspari A. Phase I/II Study of Daily X 3 Navelbine with an Attempt at Dose-Escalation with Filgrastim in Metastatic Breast Cancer. ASCO. 1996; 154a
  • Budman D., Weiselberg L., O'Mara V. A Phase I study of sequential vinorelbine followed by paclitaxel. Ann. Oncol. 1999; 10: 861–863, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Gershenson D., Burke T., Morris M., Bast R., Guaspari A., Hohneker J., Wharton J. A phase I study of a daily X3 schedule of intravenous vinorelbine for refractory epithelial ovarian cancer. Gynecol. Oncol. 1998; 70(3)404–409, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
  • Masters G., Hoffman P., Hsieh A., Drinkard L., Mick R., Samuels B., Guaspari A., Golomb H., Vokes E. Phase I study of vinorelbine and ifosfamide in advanced non-small-cell lung cancer. J. Clin. Oncol. 1997; 15(3)884–892, [PUBMED], [INFOTRIEVE]
  • Spiridonidis C., Laufman L., Jones J. Daily Vinorelbine-Cisplatin in Patients with Advanced Non-Small Cell Lung Cancer: A Feasibility Trial of a New Schedule. ASCO. 1997; 483a, #1738
  • Spiridonidis C., Laufman L., Jones J., Rhodes V. Daily times four vinorelbine plus cisplatin in advanced non-small cell lung cancer: a phase II study of a novel schedule. Ann. Oncol. 1999; 10: 989–991, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Pereira E., Tarasiuk J., Garnier-Suillerot A. Kinetic analysis in living cells of the inhibition of the P-glycoprotein-mediated efflux of anthracyclines by vinca alkaloids. Chem. Biol. Interact. 1998; 114(1–2)61–76, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
  • Bakker M., Groen H., Smit E. F., Smeets J., Riggi M., Postmus P. Phase I study of high-dose epirubicin and vinorelbine in previously untreated non-small-cell lung cancer stage IIIB–IV. Br. J. Cancer 1995; 72(6)1547–1550, [PUBMED], [INFOTRIEVE]
  • Peacock N., Burris H., Dieras V., Smith L., Rodriguez G., Eckardt J., Jones S., Hardy J., Hohneker J., Bigley J., Hoff D. A phase I trial of vinorelbine in combination with mitoxantrone in patients with refractory solid tumors. Invest. New Drugs 1998; 16(1)37–43, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
  • Hochster H. Combined doxorubicin/vinorelbine (Navelbine) therapy in the treatment of advanced breast cancer. Semin. Oncol. 1995; 22(2 Suppl. 5)55–59, discussion 59–60.[PUBMED], [INFOTRIEVE]
  • Llombart-Cussac A., Pivot X., Rhor-Alvarado A., Cesne A., Chevalier T., Tursz T., Spielman M. First-line vinorelbine-mitoxantrone combination in metastatic bresat cancer patients relapsing after an adjuvant anthracycline regimen: results of a phase II study. Oncology 1998; 55(5)384–390, [CSA], [CROSSREF]
  • Pronzato P., Tognoni A., Pensa F., Vaira F., Vigani A. A dose finding study for the combination of epidoxorubicin and vinorelbine, delivered every two weeks with G-CSF support, in advanced breast cancer. J. Chemother. 1998; 10(4)326–330, [PUBMED], [INFOTRIEVE]
  • Ramirez M., Marcom P., Sutton L., Harris L., Petros W., Berry D., Warmuth M., Winer E. A Phase I/II Study of Doxil and VNB in Metastatic Breast Cancer Patients. ASCO. 1998; 650
  • Gridelli C., De Placido S., Pepe R., Incoronato P., Airoma G., Rossi A., Palazzolo G., Bianco A. Phase I study of epirubicin plus vinorelbine with or without G-CSF in advanced non-small cell lung cancer. Eur. J. Cancer 1993; 12(31)1729–1731, [CROSSREF]
  • Baldini E., Tibaldi C., Chiavacci F., Lieto M. D., Fioretto L., Giallom-bardo A., Taviani R., Ghezzi P., Bolognini A., Conte P. Epirubicin/vinorelbine as first line therapy in metastatic breast cancer. Breast Cancer Res. Treat. 1998; 49(2)129–134, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
  • Blomqvist C., Hietanen P., Teerenhovi L., Rissanen P. Vinorelbine and epirubicin in metastatic breast cancer. A dose finding study. Eur. J. Cancer 1995; 31A(13–14)2406–2408, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Mathe G., Reizenstein P. Phase I pharmacologic study of a new vinca alkaloid: navelbine. Cancer Lett. 1985; 27: 285–293, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • de Jongh D., Wade J., Finley R., Joshi J., Aisner J., Wiernik P., Schimpff S. Trimethoprim/sulfamethoxazole versus placebo: a double-blind comparison of infection prophylaxis in patients with small cell carcinoma of the lung. J. Clin. Oncol. 1983; 1(5)302–307, [PUBMED], [INFOTRIEVE]
  • National Cancer Institute Common Toxicity Criteria Document. 1999, http://ctep.cancer.gov/reporting/ctc.html
  • Miller A., Hoogstraten B., Staquet M. Reporting of cancer treatment. Cancer 1981; 47: 207–214, [PUBMED], [INFOTRIEVE]
  • Jahanzeb M., Hirsch R. Phase I study of Doxil (R) in combination with escalating doses of Navelbine (R) for the treatment of patients with advanced malignancies. ASCO, asco. ASCO, Atlanta 1999; 827
  • Gebbia V., Mauceri G., Fallica G. Pegylated liposomal doxorubicin with escalating dose vinorelbine in metastatic breast carcinoma: a dose finding study. ASCO. ASCO, Atlanta 1999; 811
  • Burstein H., Ramirez M., Petros W. Phase I study of Doxil and vinorelbine in metastatic breast cancer. Ann. Oncol. 1999; 10(9)1113–1116, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Hoff P., Valero V., Ibrahim N., Willey J., Hortobagyi G. Hand-foot syndrome following prolonged infusion of high doses of vinorelbine. Cancer 1998; 82(5)965–969, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • Kouroukis C., Hings I. Respiratory failure following vinorelbine tartrate infusion in a patient with non-small cell lung cancer. Chest 1997; 112(3)846–848, [PUBMED], [INFOTRIEVE]

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