Spots Global Cancer Trial Database for SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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Trial Identification

Brief Title: SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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

Study ID: NCT00028015

Conditions

Colorectal Cancer

Interventions

SarCNU

Study Description

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.