Irofulven in Treating Patients With Metastatic Colorectal Cancer

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.

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.

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

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)

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