Chemotherapy Plus Trastuzumab in Treating Patients With Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of vinorelbine plus trastuzumab in treating patients who have refractory or metastatic breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Trastuzumab; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unresectable or metastatic non-small cell lung cancer

• Stage IIIB or IV (closed to accrual as of 4/16/01) OR

• Histologically confirmed locally advanced breast cancer that has progressed after first-line chemotherapy or metastatic breast cancer

• HER-2/neu overexpression (1+ to 3+)

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Menopausal status:

• Not specified

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• ALT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2 times ULN

Cardiovascular:

• No prior or concurrent unstable angina

• No prior symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• LVEF at least 45% by echocardiogram or MUGA if received prior anthracycline or anthrapyrazole therapy

Other:

• No prior hypersensitivity to trastuzumab, Chinese hamster ovary cell proteins, or any component of these products

• No other medical illness that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior trastuzumab (Herceptin)

Chemotherapy:

• See Disease Characteristics

• No prior vinorelbine

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified