Phase II Study of MGI-114 (NSC# 683863) Administered Intravenously for Five Days Every 28 Days to 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Antitumor Activity of MGI-114
Every 28 day cycle
No
Paulo Hoff, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
DM97-308
NCT00003441
August 1998
November 2000
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |