Capecitabine in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.

• Phase: Phase 2
• 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: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

• Evidence of metastatic involvement (stage IV disease)

• Patients must have measurable disease

• At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)

• Treated brain metastases (surgery or radiation therapy) allowed if clinically stable

• Patients with leptomeningeal disease are ineligible

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Male or female

• Menopausal status not specified

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

• Platelet count ≥ 100,000/mm^3

• Creatinine clearance > 50 mL/min

• Fertile patients must use effective contraception

• No history of another severe and/or life-threatening medical disease

• No other active primary malignancy

• Not pregnant or nursing

• Negative pregnancy test

• Patients with asymptomatic HIV infection are eligible

• Liver dysfunction score ≤ 9

• No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)

• No active gastrointestinal malabsorption illness

• No clinically significant cardiac disease, including the following:

• Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months

• No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency

• No history of uncontrolled seizures or central nervous system disorders

• No significant history of noncompliance to medical regimens

• No clinically significant psychiatric disability that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• No previous capecitabine

• Up to 3 prior cytotoxic regimens allowed for metastatic disease

• Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)

• No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy

• No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy

• No other concurrent investigational drugs

• No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)

• Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed

• At least 4 weeks since prior sorivudine or brivudine

• Concurrent use of bisphosphonates allowed if initiated before beginning study therapy

• Concurrent use of megestrol acetate suspension as an appetite stimulant allowed