Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer

December 18, 2013 updated by: Oncotech

Assessment of the Predictive Value of the Extreme Drug Resistance (EDR) Assay in Patients Receiving Paclitaxel for Metastatic Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

100

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
    • California
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hematology/Oncology Medical Group
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Breast Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology/Oncology Associates
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

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: 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

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

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: Diagnostic

Collaborators and Investigators

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

Sponsor

Oncotech

Investigators

  • Study Chair: Rita S. Mehta, MD, Oncotech

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

  • 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.

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

July 1, 1997

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

November 25, 2003

First Posted (Estimate)

November 26, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066135
  • ONCOTECH-OTBR01
  • UCIRVINE-97-02
  • NCI-V98-1391

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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