SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00028015
- Lead Sponsor
- NCIC Clinical Trials Group
- 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 sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer.
* Determine the qualitative and quantitative toxicity of this drug in these patients.
* Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Hopital Notre- Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
McGill University
🇨🇦Montreal, Quebec, Canada