Phase II study of rubitecan, an oral camptothecin in patients with advanced colorectal cancer who have failed previous 5-fluorouracil based chemotherapy

Investigational New Drugs
Hitendra PatelRamesh K Ramanathan

Abstract

Rubitecan (RFS-2000, 9NC, Orathecin) is an orally bioavailable camptothecin analogue, with evidence of preclinical activity in colon cancer cell lines. We evaluated oral rubitecan (5 days on, 2 days rest per week) on a continuous schedule, in patients with advanced colorectal cancer (CRC), who progressed after 5-fluorouracil based chemotherapy. Fourteen eligible patients were treated with rubitecan at 1.5 mg/m2/day on a 5 day/week continuous schedule. Therapy was well tolerated with most adverse events in the mild to moderate category. Grade 3/4 toxicity consisting of anemia, diarrhea and elevated bilirubin was seen in 4 patients. No responses were seen in 13 evaluable patients. Overall median survival (95% confidence interval) was 10.1 (range 3.1-12.6) months, and median time to progression was 2.1 months. Administration of rubitecan was well tolerated, but this schedule does not appear to have clinical activity in patients with advanced previously treated CRC.

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Citations

Sep 21, 2007·Cancer Chemotherapy and Pharmacology·Francesco CaponigroPatricia Pollard
Dec 4, 2013·Future Oncology·Raj Kumar Shukla
Jan 9, 2016·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Jian ZhengFanfan Zhou
Sep 11, 2012·Drug Discovery Today·Silvia MazzaferroGilles Ponchel

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