A Phase I Dose-Finding Study Using an Innovative Sequential Biweekly Schedule of Irinotecan Followed 24 Hours Later by Capecitabine

REFERENCES

• Pizzolato J. F., Saltz L. B. The camptothecins. Lancet 2003; 361: 2235–2242
   PubMed Web of Science ®Google Scholar
• Budman D. R. Capecitabine. Invest. New Drugs 2000; 18: 355–363
   PubMed Web of Science ®Google Scholar
• Tewes M., Schleucher N., Achterrath W., et al. Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study dagger. Ann. Oncol. 2003; 14: 1442–1448
   PubMed Web of Science ®Google Scholar
• Goel S., Jhawer M., Rajdev L., et al. Phase I clinical trial of irinotecan with oral capecitabine in patients with gastrointestinal and other solid malignancies. Am. J. Clin. Oncol. 2002; 25: 528–534
   PubMed Web of Science ®Google Scholar
• Patt Y. Z., Lin E., Leibmann J., et al. Capecitabine plus irinotecan for chemotherapy-naïve patients with metastatic colorectal cancer (MCRC): US multicenter phase II trial. Proc. Am. Soc. Clin. Oncol. 2003; 22: 281, (Abst. 1130)
   Google Scholar
• Gold P. J., Godfrey T., Dhami M., et al. Capecitabine and irinotecan as 1st line therapy for patients with metastatic colorectal cancer: phase II study preliminary results. Proc. Am. Soc. Clin. Oncol. 2003; 22: 288, (Abstr. 1158)
   Google Scholar
• Bajetta E., Di Bartolomeo M., Mariani L., et al. Randomized multicenter phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer 2004; 100: 279–287
   PubMed Web of Science ®Google Scholar
• Han J. Y., Lee D. H., Kim H. Y., et al. A phase II study of weekly irinotecan and capecitabine in patients with previously treated non-small cell lung cancer. Clin. Cancer Res. 2003; 9: 5909–5914
   PubMed Web of Science ®Google Scholar
• Kerr D. Capecitabine/irinotecan in colorectal cancer: European early-phase data and planned trials. Oncology (Huntington) 2002; 16: 12–15
   PubMed Web of Science ®Google Scholar
• Perez E., Hillman D., Mailliard J., et al. Randomized phase II study of 2 schedules of irinotecan (CPT-11) for patients with refractory metastatic breast cancer: a NCCTG Cooperative Group study. Ann. Proc. Am. Soc. Clin. Oncol. 2002; 21: 206a
   Google Scholar
• O'Shaughnessy J. A. The evolving role of capecitabine in breast cancer. Clin. Breast Cancer. 2003; 4: S20–S25, (Suppl. 1)
   PubMedGoogle Scholar
• Seidman A. D. Monotherapy options in the management of metastatic breast cancer. Semin. Oncol. 2003; 30: 6–10
   PubMed Web of Science ®Google Scholar
• Goldberg R. M., Sargent D. J., Morton R. F., et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J. Clin. Oncol. 2004; 22: 23–30
   PubMed Web of Science ®Google Scholar
• Budman D. R., Calabro A., Kreis W. Synergistic and antagonistic combinations of drugs in human prostate cancer cell lines in vitro. Anticancer Drugs 2002; 13: 1011–1016
   PubMed Web of Science ®Google Scholar
• Budman D R, Calabro A. In vitro search for synergy and antagonism: evaluation of docetaxel combinations in breast cancer cell lines. Breast Cancer Res. Treat. 2002; 74: 41–46
   PubMed Web of Science ®Google Scholar
• Cao S., Rustum Y. M. Synergistic antitumor activity of irinotecan in combination with 5-fluorouracil in rats bearing advanced colorectal cancer: role of drug sequence and dose. Cancer Res. 2000; 60: 3717–3721
   PubMed Web of Science ®Google Scholar
• Cao S., Hapke G., Rustum Y. Enhanced antitumor activity of Xeloda by irinotecan in nude mice bearing human A253 and FaDu head and neck xenografts. Proc. Am. Assoc. Cancer Res. 2001; 42: 86a, (Abstr. 464)
   Google Scholar
• Azrak R. G., Cao S., Slocum H. K., et al. Therapeutic synergy between irinotecan and 5-fluorouracil against human tumor xenografts. Clin. Cancer Res. 2004; 10: 1121–1129
   PubMed Web of Science ®Google Scholar
• Pitot H. C., Goldberg R. M., Reid J. M., et al. Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy. Clin. Cancer Res. 2000; 6: 2236–2244
   PubMed Web of Science ®Google Scholar
• Cassidy J., Twelves C., Van Cutsem E., et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann. Oncol. 2002; 13: 566–575
   PubMed Web of Science ®Google Scholar
• Ezzeldin H., Diasio R. Pharmacogenetics and cancer chemotherapy. Handbook of Anticancer Drug Development, D. Budman, A. Calvert, E. Rowinsky. Lippincott Williams & Wilkins, Baltimore 2003; 343–378
   Google Scholar
• Villeneuve L., Girard H., Fortier L. C., et al. Novel functional polymorphisms in the UGT1A7 and UGT1A9 glucuronidating enzymes in Caucasian and African-American subjects and their impact on the metabolism of 7-ethyl-10-hydroxycamptothecin and flavopiridol anticancer drugs. J. Pharmacol. Exp. Ther. 2003; 307: 117–128
   PubMed Web of Science ®Google Scholar
• Innocenti F., Undevia S. D., Iyer L., et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J. Clin. Oncol. 2004; 22: 1382–1388
   PubMed Web of Science ®Google Scholar
• Yue L., Saikawa Y., Ota K., et al. A functional single-nucleotide polymorphism in the human cytidine deaminase gene contributing to ara-C sensitivity. Pharmacogenetics 2003; 13: 29–38
   PubMedGoogle Scholar