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Bexarotene in Treating Patients With Metastatic Breast Cancer

Sponsor
Ligand Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00003752
Collaborator
(none)
180
Enrollment
30
Locations
53
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer
Study Start Date :
Oct 1, 1998
Actual Study Completion Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Ligand Pharmaceuticals

    Investigators

    • Study Chair: George D. Demetri, MD, Dana-Farber Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003752
    Other Study ID Numbers:
    • LIGAND-L1069-34
    • CDR0000066873
    • MSKCC-99008
    • UMN-9808M00110
    First Posted:
    May 25, 2004
    Last Update Posted:
    May 30, 2013
    Last Verified:
    May 1, 2007
    Keywords provided by , ,
    stage IV breast cancer
    recurrent breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Bexarotene

    Study Results

    No Results Posted as of May 30, 2013