Bexarotene in Treating Patients With Metastatic Breast Cancer

May 29, 2013 updated by: Ligand Pharmaceuticals

A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of bexarotene in treating patients who have metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose levels in patients with advanced breast cancer. II. Assess the safety and tolerability of this treatment regimen in this patient population. III. Evaluate the efficacy of oral bexarotene in terms of induction of differentiation and decreased aberrant cell proliferation in these patients.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to prior therapy for metastatic disease. Patients are randomized to one of two dose levels. All patients receive oral bexarotene once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every week for the first month, at weeks 6 and 8, then monthly thereafter.

PROJECTED ACCRUAL: A total of 84-180 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama Comprehensive Cancer Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 91010
        • Beckman Research Institute, City of Hope
      • San Diego, California, United States, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Francisco, California, United States, 94115-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Vincent T. Lombardi Cancer Research Center, Georgetown University
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Baptist Regional Cancer Institute - Jacksonville
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2822
        • Louisiana State University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Nebraska
      • Omaha, Nebraska, United States, 68198-3330
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants Inc
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Cancer Center at Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon-Minnie Pearl Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center, University of Virginia HSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer No CNS metastases No rapidly progressing visceral disease Previously irradiated lesions(s) may be designated as measurable indicator tumor(s) only if more than 6 months since radiotherapy, patient has no other measurable disease regrowth, and bidimensionally measurable regrowth is documented within 2 months prior to study Stratum 1 (hormonal): Must be hormone receptor positive (ER or PR) Prior hormonal therapy only allowed for metastatic disease Must have progressed on last hormonal regimen Must have at least one bidimensionally measurable tumor Stratum 2 (chemotherapy): Hormone receptor positive or negative Must have progressed on or after prior chemotherapy (1-2 regimens) for metastatic disease (bone marrow transplant counts as 2 regimens) Prior hormonal therapy allowed Must have at least one bidimensionally measurable tumor Stratum 3 (tamoxifen): Must be hormone receptor positive (ER or PR) and progressing on tamoxifen No symptomatic visceral metastasis if on adjuvant tamoxifen at time of systemic recurrence Must have at least one bidimensionally measurable tumor, or lytic bone lesion which measures at least one cm in diameter Hormone receptor status: See above

PATIENT CHARACTERISTICS: Age: Over 18 Menopausal status: Not specified Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Fasting triglycerides within normal range Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN Concurrent medication with drugs that significantly alter hepatic metabolism (e.g., phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable Renal: Creatinine less than 2 times ULN OR Creatinine clearance greater than 40 mL/min Concurrent medication with drugs that significantly alter renal metabolism (e.g., probenecid) allowed only if dosage stable Other: At least 5 years since any other prior invasive malignancy except basal cell and squamous cell carcinoma of the skin No serious concurrent illness that would prevent compliance No history of or clinically significant risk factors for developing pancreatitis Fasting triglycerides within normal range Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior monoclonal antibody HER2 therapy for metastatic disease allowed only if combined with chemotherapy or hormonal therapy and treatment failed No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy (at least 6 weeks since prior mitomycin or nitrosourea) No prior retinoid therapy for breast cancer At least 3 months since any other prior retinoid therapy except topical application for dermatological indications No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 2 weeks since prior non-FDA approved hormonal therapy No other concurrent hormonal therapy except chronic low dose hormone replacement therapy or low dose corticosteroids for noncancer indication Radiotherapy: See Disease Characteristics Prior radiotherapy allowed Concurrent radiotherapy allowed only to non-indicator tumor(s) that do not represent new disease or disease progression Surgery: Prior surgery allowed Other: At least one month since prior investigational therapy (except hormonal) No other concurrent investigational therapy Concurrent medication with drugs that significantly alter hepatic metabolism (e.g., phenobarbital, phenytoin, oral azole antifungals) allowed only if dosage stable No more than 15,000 IU of vitamin A consumed daily

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligand Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 24, 2004

First Posted (Estimate)

May 25, 2004

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIGAND-L1069-34
  • CDR0000066873 (Registry Identifier: PDQ (Physician Data Query))
  • MSKCC-99008
  • UMN-9808M00110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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