ORLANDO—Combination therapy with irinotecan(Drug information on irinotecan) (CPT-11, Camptosar) and capecitabine(Drug information on capecitabine) (Xeloda) has the potential to become a mainstay of treatment for colorectal cancer, according to David J. Kerr, MD, Rhodes Professor of Therapeutics and Clinical Pharmacology and director of the National Translational Cancer Research Network, Oxford University.
Both drugs are active as single agents, show minimal overlap in toxicities, and have been highly active in xenograft models.
Speaking at an industry-sponsored symposium held in conjunction with the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO), Dr. Kerr discussed European phase I/II clinical trials of the combination and future phase III investigations.
Dr. Kerr is the lead investigator in an irinotecan/capecitabine study conducted in the United Kingdom and The Netherlands.
"The patients in the UK/Netherlands study may have received fluorouracil(Drug information on fluorouracil) (5-FU)/leucovorin in an adjuvant setting, but they were chemotherapy naïve in terms of treatment for their advanced disease," Dr. Kerr said. "We saw responses at every dose level. Looking at the totality, there was a 52% overall response rate. So the combination maintained a very decent response rate, and we saw it all the way across."
Dose-limiting toxicities were diarrhea and neutropenia. The investigators chose a dosage level of 250 mg/m² bid of irinotecan and 1,000 mg/m² bid of capecitabine on days 1 to 14 for their upcoming phase III trial. At this dosage level, hand-foot syndrome was not a problem.
Confirmatory Studies
