Nitrocamptothecin in Treating Patients With Advanced or Recurrent Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00005877
- Lead Sponsor
- Astex Pharmaceuticals, Inc.
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced or recurrent colorectal cancer.
- Detailed Description
OBJECTIVES: I. Determine the objective response rate, overall survival, and time to disease progression after maximal response in patients with advanced or metastatic colorectal cancer treated with oral nitrocamptothecin. II. Determine the safety, toxicity, and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 8 may receive additional courses. Patients are followed every 3 months for 1 year or until death.
PROJECTED ACCRUAL: Approximately 14-45 patients will be accrued for this study over less than 1 year.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SuperGen, Incorporated
🇺🇸Dublin, California, United States