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Irofulven in Treating Patients With Metastatic Breast Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00003796
Collaborator
(none)
32
Enrollment
1
Location
1
Arm

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  1. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.

  2. Assess the qualitative and quantitative toxic effects of this drug in these patients.

  3. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
Study Start Date :
May 1, 1999
Actual Primary Completion Date :
Dec 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: irofulven

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Lisa Hammond, MD, The University of Texas Health Science Center at San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00003796
    Other Study ID Numbers:
    • CDR0000066939
    • UTHSC-IDD-98-23
    • SACI-IDD-98-23
    • NCI-T98-0060
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Feb 11, 2013
    Last Verified:
    Mar 1, 2003
    Keywords provided by National Cancer Institute (NCI)
    stage IV breast cancer
    recurrent breast cancer
    male breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Irofulven

    Study Results

    No Results Posted as of Feb 11, 2013