Status:
TERMINATED
Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
21-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givi...
Detailed Description
OBJECTIVES: * Assess the efficacy of sequential use of epirubicin hydrochloride followed by vinorelbine ditartrate in patients with stage IIB, IIIA, IIIB, or IV breast cancer. * Measure the biologica...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed stage IIB (T3, N0), IIIA, IIIB, or IV breast carcinoma
- Original tumor must be available for analysis of p53 status
- Measurable disease, defined as any lesion that can be accurately measured in ≥ 1 dimension with longest diameter ≥ 20 mm using conventional techniques OR ≥ 10 mm with spiral CT scan
- Stage IIIB disease will be assessed by clinical exam (monitoring skin changes as well as tumor size)
- No visceral crisis (lymphangitic pulmonary spread, or liver or marrow replacement sufficient to cause significant organ dysfunction)
- No untreated CNS metastases
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 8 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Bilirubin normal
- AST ≤ 3 times normal (≤ 5 times normal if liver metastases are present)
- Creatinine ≤ 1.5 mg/dL
- Ejection fraction ≥ lower limit of normal by MUGA scan or ECG
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No other malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- No pre-existing disease (i.e., cardiac, pulmonary, neurologic, or other disease) that the investigator judges to be clinically significant
- No active infectious process, severe malnutrition, or intractable emesis
- PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- At least 3 weeks since prior radiotherapy
- At least 3 weeks since prior chemotherapy
- Maximum prior doxorubicin hydrochloride dose must be ≤ 300 mg/m² OR equivalent anthracycline (epirubicin hydrochloride) dose must be ≤ 540 mg/m² OR calculated total anthracycline dose must be ≤ 540 mg/m² (determined as 1.8 times total doxorubicin hydrochloride dose plus epirubicin hydrochloride dose)
- No prior chemotherapy for metastatic disease
- Prior adjuvant chemotherapy, radiotherapy, and/or hormonal therapy for breast cancer allowed
- No concurrent radiotherapy except for brain metastases
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00176488
Start Date
June 1 2003
End Date
October 1 2009
Last Update
March 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903