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 colorectal cancer.
OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene (MGI-114) when given daily for 5 days every 28 days to patients with metastatic adenocarcinoma of the colon or rectum. II. Evaluate the qualitative and quantitative toxicities of MGI-114 given on this schedule in this patient population. OUTLINE: Patients receive 6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days. Courses are repeated every 28 days. The minimum treatment period is 2 courses. Treatment continues indefinitely in the absence of unacceptable toxic effects or disease progression. Patients are followed at the end of every other course while on the study, and then every 3 months thereafter until death. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 6-10 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Antitumor Activity of MGI-114
Time frame: Every 28 day cycle
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