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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Rita S. Mehta, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oncotech

Authority:

United States: Federal Government

Study ID:

CDR0000066135

NCT ID:

NCT00003253

Start Date:

July 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

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