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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
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Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Notre- Dame du CHUM
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada