Colorectal Cancer Clinical Trial
Official title:
A Phase II Trial of MGI-114 (NSC# 683863) Administered as a 5-Minute Infusion Daily for Five Days Every 4 Weeks in Patients With Previously Untreated Advanced 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 irofulven in treating patients with
metastatic or recurrent colorectal cancer.
OBJECTIVES: I. Determine the objective response rate of patients with metastatic or locally
recurrent adenocarcinoma of the colon or rectum treated with 6-hydroxymethylacylfulvene
(MGI-114). II. Determine the toxicity of this treatment regimen in this patient population.
III. Study pharmacokinetics of MGI-114 in these patients. IV. Determine the relationship
between pharmacokinetics of MGI-114 and clinical outcomes including toxicity and response to
therapy in these patients.
OUTLINE: This is an open label, multicenter study. Patients receive
6-hyroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 days. Courses are repeated
every 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable
toxic effects or disease progression. Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 6-12
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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