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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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or locally recurrent
adenocarcinoma of the colon or rectum Bidimensionally measurable disease Lesions seen on
colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and
ascites are not considered measurable No CNS disease only CNS metastases with other sites
of measurable disease allowed provided appropriate therapy for CNS metastases has been
administered and patient is neurologically stable and does not require intravenous steroid
or anticonvulsant therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Zubrod 0-2 Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 (no platelet transfusion
within 7 days) Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL
Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no greater
than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No significant
uncontrolled medical or psychiatric illness No serious active infection No other active
malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless
adequately treated and less than 30% risk of relapse

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic use of growth
factors except for documented febrile neutropenia or sepsis Chemotherapy: At least 12
months since prior fluorouracil based adjuvant or neoadjuvant chemotherapy No more than 1
prior regimen No prior chemotherapy for advanced metastatic colorectal cancer No other
concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine
therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No prior radiotherapy to the only site of measurable disease No
concurrent radiotherapy Surgery: Not specified Other: See Disease Characteristics At least
30 days since prior investigational drug

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response Rate

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

November 2000

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



University of Chicago Cancer Research Center Chicago, Illinois  60637
Lutheran General Cancer Care Center Park Ridge, Illinois  60068
James Graham Brown Cancer Center Louisville, Kentucky  40202
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
University of Illinois at Chicago Chicago, Illinois  60612
Cancer Care Specialists of Central Illinois, S.C. Decatur, Illinois  62526
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne, Indiana  46885-5099
Michiana Hematology/Oncology P.C. South Bend, Indiana  46617
Illinois Oncology Research Association Peoria, Illinois  61602