Colorectal Cancer Clinical Trial
Official title:
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
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.
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