Irofulven in Treating Patients With Metastatic Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-08-31

Study Completion Date

2000-11-08

Brief Summary

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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 colorectal cancer.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irofulven

6-hydroxymethylacylfulvene (MGI-114) IV over 5 minutes daily for 5 consecutive days every 28 day cycle.

Group Type EXPERIMENTAL

Irofulven (MGI-114)

Intervention Type DRUG

IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.

Interventions

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Irofulven (MGI-114)

IV over 5 minutes daily for 5 consecutive days. Courses repeated every 28 days. Minimum treatment period is 2 courses.

Intervention Type DRUG

Other Intervention Names

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6-hydroxymethylacylfulvene MGI-114

Eligibility Criteria

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Inclusion 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No