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Home > "B" Clinical Trials Conditions > Bexarotene in Treating Patients With Metastatic Breast Cancer  Bexarotene in Treating Patients With Metastatic Breast Cancer
Bexarotene in Treating Patients With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Ligand Pharmaceuticals ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeDemetri, Study Chair, Ligand Pharmaceuticals
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Hematology Oncology Consultants Inc
Columbus, Ohio, 43235
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Additional Information:
Study ID Numbers: CDR0000066873; LIGAND-L1069-34,MSKCC-99008,UMN-9808M00110
Study Start Date: October 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003752
Other Stage 4 Breast Cancer Studies:
1. Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer
2. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
3. Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
4. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
5. Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bexarotene in Treating Patients With Metastatic Breast Cancer
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