Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy such as docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving docetaxel with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with imatinib mesylate in treating patients with locally advanced or metastatic breast cancer.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Imatinib Mesylate

Criteria

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