Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

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

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving docetaxel and carboplatin together with pegfilgrastim before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together with pegfilgrastim works in treating patients who are undergoing surgery for stage II or stage III breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Clinical stage II or III disease (including T2-4, N0-3)

• No clinical or radiological evidence of distant metastases

• Isolated supraclavicular lymph node involvement allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10.0 g/dL

Hepatic

• Bilirubin normal

• Meets 1 of the following criteria:

• AST or ALT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase normal

• AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

• AST or ALT normal AND alkaline phosphatase ≤ 5 times ULN

Renal

• Creatinine clearance ≥ 30 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 30 days after study treatment

• No active unresolved infection

• No history of severe hypersensitivity reaction to docetaxel, carboplatin, or any other drug formulated with polysorbate 80

• No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or pegfilgrastim

• No peripheral neuropathy ≥ grade 2

• No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Surgery

• No prior surgical resection for invasive breast cancer

Other

• No other prior therapy for invasive breast cancer