Irofulven in Treating Patients With Metastatic or Recurrent Colorectal Cancer
- Registration Number
- NCT00003786
- Lead Sponsor
- University of Chicago
- Brief 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 irofulven in treating patients with metastatic or recurrent colorectal cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A irofulven MGI-114 (11mg/m2/day x 5 days every 28 days)
- Primary Outcome Measures
Name Time Method Clinical Response Rate 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Michiana Hematology/Oncology P.C.
🇺🇸South Bend, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
🇺🇸Decatur, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States