Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
NCT ID: NCT00003253
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
1997-07-31
Brief Summary
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PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer.
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Detailed Description
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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.
Conditions
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Study Design
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DIAGNOSTIC
Interventions
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paclitaxel
antitumor drug screening assay
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Oncotech
INDUSTRY
Principal Investigators
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Rita S. Mehta, MD
Role: STUDY_CHAIR
Oncotech
Locations
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Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States
Long Beach Memorial Breast Center
Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Howard University
Washington D.C., District of Columbia, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Fruehauf JP, Mehta RS, Parker RJ: Association of invitro resistance to paclitaxel with clinical outcome in metastatic breast cancer patients with taxol: a multi-institutional prospective trial. [Abstract] Proc Am Assoc Cancer Res 41: A-2096, 330, 2000.
Other Identifiers
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ONCOTECH-OTBR01
Identifier Type: -
Identifier Source: secondary_id
UCIRVINE-97-02
Identifier Type: -
Identifier Source: secondary_id
NCI-V98-1391
Identifier Type: -
Identifier Source: secondary_id
CDR0000066135
Identifier Type: -
Identifier Source: org_study_id
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