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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 (NCT00003786)

National Cancer Institute (NCI)
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.
  • Drug: irofulven
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    9 locations

    United States (9)
    • University of Illinois at Chicago
      Chicago, Illinois, United States, 60612
    • University of Chicago Cancer Research Center
      Chicago, Illinois, United States, 60637
    • Louis A. Weiss Memorial Hospital
      Chicago, Illinois, United States, 60640
    • Cancer Care Specialists of Central Illinois, S.C.
      Decatur, Illinois, United States, 62526
    • Lutheran General Cancer Care Center
      Park Ridge, Illinois, United States, 60068
    • Illinois Oncology Research Association
      Peoria, Illinois, United States, 61602
    • Fort Wayne Medical Oncology and Hematology, Inc.
      Fort Wayne, Indiana, United States, 46885-5099
    • Michiana Hematology/Oncology P.C.
      South Bend, Indiana, United States, 46617
    • James Graham Brown Cancer Center
      Louisville, Kentucky, United States, 40202
    Status:
    withdrawn
    Type:
    Interventional
    Phase:
    Start:
    31 March, 1999
    Updated:
    05 March, 2014
    Participants:
    0
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