Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug.

PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer not eligible for potentially curative therapy or studies of higher priority

• Advanced disease

• Tumor accessible to biopsy AND not irradiated

• Failed at least 1 prior chemotherapy regimen (not including adjuvant chemotherapy)

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST ≤ 2 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN OR

• Creatinine clearance ≥ 50 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No active uncontrolled bacterial, viral, or fungal infection

• No poor medical risk from non-malignant systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• Prior irinotecan allowed

• Prior carboplatin allowed

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy except for small port radiotherapy for local control

Surgery

• More than 4 weeks since prior major surgery

Other

• No concurrent high-dose IV cyclosporine