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 colorectal cancer.

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

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed metastatic adenocarcinoma of the colon or rectum
• Bidimensionally measurable lesions; Sentinel lesions outside the field of any prior radiation therapy
• No confirmed or suspected brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent biologic therapy
• Chemotherapy: No prior chemotherapy for metastatic disease; At least 6 months since prior adjuvant chemotherapy; No other concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiation therapy and recovered; No concurrent radiotherapy
• Surgery: At least 4 weeks since prior major surgery and recovered; No concurrent surgery
• Other: At least 28 days since prior administration of any investigational drug; No other concurrent anticancer therapy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-1
• Life expectancy: At least 12 weeks
• Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 mg/dL
• Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min
• Cardiovascular: No active congestive heart failure; No uncontrolled angina; At least 6 months since prior myocardial infarction; No uncontrolled hypertension
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No concurrent serious infection; No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix; No overt psychosis or mental disability; No life threatening illness (unrelated to tumor)

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Paulo Hoff,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000066469; MDA-DM-97308; NCI-T97-0113
Record last reviewed:  September 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003441
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-25