Irofulven in Treating Patients With Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003441|
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Irofulven (MGI-114)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of MGI-114 (NSC# 683863) Administered Intravenously for Five Days Every 28 Days to Patients With Metastatic Colorectal Cancer|
|Study Start Date :||August 1998|
|Actual Primary Completion Date :||November 2000|
|Actual Study Completion Date :||November 2000|
6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days every 28 day cycle.
Drug: Irofulven (MGI-114)
IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.
- Antitumor Activity of MGI-114 [ Time Frame: Every 28 day cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003441
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Paulo Hoff, MD||M.D. Anderson Cancer Center|