Irofulven in Treating Patients With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003796
• Other study ID #: CDR0000066939
• Secondary ID: UTHSC-IDD-98-23S
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 8, 2013
• Start date: May 1999

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• irofulven

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,