ORLANDOCombination therapy with irinotecan (CPT-11, Camptosar) and
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 (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.