Irofulven in Treating Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description
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OBJECTIVES: I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven. II. Assess the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Official Title
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Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: irofulven


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy Must have received 1 or 2 prior chemotherapy regimens for metastatic disease More than 3 prior regimens allowed No active brain metastases or meningeal breast cancer involvement PATIENT CHARACTERISTICS: Sex: Male or female Performance status: SWOG 0-2 Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of myocardial infarction or unstable angina within the past 6 months No uncontrolled congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease) No history of retinopathy and/or macular degeneration PRIOR CONCURRENT THERAPY: Chemotherapy: No prior irofulven
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: irofulven<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, male breast cancer