Phase II study of rubitecan, an oral camptothecin in patients with advanced colorectal cancer who have failed previous 5-fluorouracil based chemotherapy
| Autor: | Ronald G. Stoller, Douglas M. Potter, William C. Zamboni, Hitendra Patel, Amy Schmotzer, Miklos L Auber, Gauri J. Kiefer, Khalid Matin, Chao Cai, Ramesh K. Ramanathan |
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| Rok vydání: | 2006 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Anemia Colorectal cancer medicine.medical_treatment Phases of clinical research Administration Oral Antineoplastic Agents Internal medicine Rubitecan Medicine Humans Pharmacology (medical) Treatment Failure Adverse effect Aged Pharmacology Chemotherapy business.industry Middle Aged medicine.disease Survival Analysis Treatment Outcome Fluorouracil Drug Resistance Neoplasm Camptothecin Female business Colorectal Neoplasms medicine.drug |
| Zdroj: | Investigational new drugs. 24(4) |
| ISSN: | 0167-6997 |
| Popis: | 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/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. Conclusions: Administration of rubitecan was well tolerated, but this schedule does not appear to have clinical activity in patients with advanced previously treated CRC. |
| Databáze: | OpenAIRE |
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