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 6-hydroxymethylacylfulvene in treating patients with metastatic or recurrent colorectal cancer.

Condition	Treatment or Intervention	Phase
recurrent colon cancer adenocarcinoma of the rectum Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer adenocarcinoma of the colon	Drug: -hydroxymethylacylfulvene	Phase II

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

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

Study chairs or principal investigators

Hedy L. Kindler,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000066919; UCCRC-9635; NCI-T98-0008
Record last reviewed:  August 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003786
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-22