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Home > "E" Clinical Trials Conditions > Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer  Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer,Male Breast Cancer
Status: No longer recruiting
Sponsor(s): Oncotech ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some patients may develop a resistance to chemotherapy drugs. PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer.
Details: OBJECTIVES: I. Evaluate the proportion of patients with extreme, intermediate, and low drug resistance to paclitaxel using the Extreme Drug Resistance (EDR) Assay in patients with previously treated metastatic breast cancer. II. Assess response to paclitaxel therapy in patients who have undergone a pretreatment EDR assay. III. Assess time to tumor progression during paclitaxel therapy in patients who have undergone a pretreatment EDR assay. IV. Determine prospectively the predictive value of the EDR assay relative to clinical outcome by correlating assay results with clinical tumor response and time to tumor progression during paclitaxel therapy in these patients. PROTOCOL OUTLINE: This is an open label, single arm, blinded study. Patients' tumor tissue samples are collected by excisional biopsy, core biopsy, or malignant fluid aspiration, then tested by the Extreme Drug Resistance (EDR) Assay to determine probability of drug resistance to paclitaxel. After successful completion of the EDR assay (approximately 7 days), patients receive paclitaxel by intravenous infusion over 1-3 hours; treatment is repeated every 3 weeks. Treatment continues until there is documented evidence of tumor progression or unacceptable toxicity. Patients' clinical response to paclitaxel therapy is compared with the response predicted by the EDR assay. PROJECTED ACCRUAL: 100 patients will be accrued to this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Metastatic breast cancer that is accessible for biopsy or aspiration - Bidimensionally measurable disease with at least one diameter greater than 1 cm documented on x-ray or photograph, or a palpable lesion - No brain metastases or carcinomatous meningitis - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; Prior paclitaxel permitted if patient had disease-free interval of greater than 1 year; Prior taxotere permitted - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Sex: Male or female - Menopausal status: Not specified - Performance status: SWOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if metastatic to liver) - Renal: Creatinine no greater than 2.0 mg/dL; Calcium no greater than 12 mg/dL - Cardiovascular: No myocardial infarction within 3 months prior to study; No unstable angina or symptomatic congestive heart failure - Other: No active or uncontrolled infection; Not HIV positive; No psychoses; Not pregnant or nursing; Effective contraception required of fertile women; No second malignancy within past 5 years except: Adequately treated basal or squamous cell carcinoma of the skin; In situ cancer of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RitaMehta, Study Chair, Oncotech
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
United States
Long Beach Memorial Breast Center
Long Beach, California, 90806
United States
Howard University
Washington D.C., District of Columbia, 20059
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, 29303
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Additional Information:
Study ID Numbers: CDR0000066135; ONCOTECH-OTBR01,NCI-V98-1391,UCIRVINE-97-02
Study Start Date: July 1997
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003253
Other Male Breast Cancer Studies:
1. Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline and/or a Taxane
2. Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
3. Vaccine Therapy in Treating Women With Metastatic Breast Cancer
4. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
5. Docetaxel in Treating Patients With Metastatic Breast Cancer
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Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
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