Irofulven in Treating Patients With Metastatic Breast Cancer

NCT ID: NCT00003796

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31

Brief Summary

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

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

irofulven

Intervention Type: DRUG

Interventions

irofulven

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Hammond, MD

Role: STUDY_CHAIR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

UTHSC-IDD-98-23

Identifier Type: -

Identifier Source: secondary_id

SACI-IDD-98-23

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0060

Identifier Type: -

Identifier Source: secondary_id

CDR0000066939

Identifier Type: -

Identifier Source: org_study_id