NCT00028015

SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SarCNU

Timeline

• Start date: 2001-10-30
• Primary completion: 2003-09-22
• Completion: 2008-09-22
• First posted: 2003-01-27
• Last updated: 2020-04-09

Locations

7 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study