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

Hitendra Patel, Ronald Stoller, Miklos Auber, Douglas Potter, Chao Cai, William Zamboni, Gauri Kiefer, Khalid Matin, Amy Schmotzer, Ramesh K. Ramanathan

Research output: Contribution to journalArticle

8 Scopus citations


Background: 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-flurouracil based chemotherapy. Patients and results: Fourteen eligible patients were treated with rubitecan at 1.5 mg/m 2/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. Conclusions: Administration of rubitecan was well tolerated, but this schedule does not appear to have clinical activity in patients with advanced previously treated CRC.

Original languageEnglish (US)
Pages (from-to)359-363
Number of pages5
JournalInvestigational New Drugs
Issue number4
StatePublished - Jul 1 2006



  • Colorectal cancer
  • Phase II
  • Rubitecan

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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