A Phase I Study Of Weekly Taxotere (Docetaxel) And Gleevec (STI571, Imatinib Mesylate, CGP 57148B) In Locally Advanced Or Metastatic Breast Cancer

Fecha de inicio: 1 de diciembre de 2003

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Stage IIIB, IIIC, or IV disease * Measurable or evaluable disease * Stable brain metastases allowed provided prior surgery or radiotherapy was completed more than 90 days ago * No documented or suspected leptomeningeal disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Meets 1 of the following criteria for AST or ALT AND alkaline phosphatase: * AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN * AST or ALT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN * AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * No known acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No New York Heart Association class III or IV heart disease * No congestive heart failure * No myocardial infarction within the past 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * No other primary malignancy except those malignancies that are clinically insignificant AND do not require active intervention * No other concurrent severe and/or life-threatening medical disease * No significant history of noncompliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * At least 14 days since prior systemic trastuzumab (Herceptin®) * No concurrent trastuzumab * No concurrent biologic therapy for the primary malignancy Chemotherapy * Prior taxane therapy, including docetaxel, in the adjuvant or metastatic setting allowed * At least 21 days since prior systemic chemotherapy (14 days for weekly or oral chemotherapy and 42 days for nitrosoureas or mitomycin) * No other concurrent chemotherapy Endocrine therapy * At least 14 days since prior systemic hormonal therapy * No concurrent antiestrogen therapy * No concurrent routine systemic corticosteroid therapy except as premedication for chemotherapy * Concurrent megestrol allowed only as an appetite stimulant Radiotherapy * See Disease Characteristics * At least 14 days since prior radiotherapy * No prior radiotherapy to only site of measurable/evaluable disease unless there is new evidence of post-radiotherapy disease progression * No concurrent radiotherapy Surgery * See Disease Characteristics * More than 2 weeks since prior major surgery Other * Recovered from all prior therapy * At least 14 days since prior daily or weekly systemic investigational treatment * No concurrent warfarin for full anticoagulation * Concurrent low-dose warfarin (e.g., 1 mg/day) allowed for prophylaxis of central venous access * No concurrent treatment with any of the following: * Phenobarbital * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Hypericum perforatum (St. John's wort) * No other concurrent therapies for the primary malignancy * No other concurrent investigational drugs or systemic therapy * No concurrent bisphosphonates unless started before study therapy * No concurrent grapefruit juice