Vinflunine and Capecitabine in Treating Patients With Previously Treated Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer meeting the following criteria:
• Metastatic disease
• Previously treated with 1-2 chemotherapy regimens for metastatic disease
• Measurable disease, defined as ≥ 1 measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• No nonmeasurable disease, including any of the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural or pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Abdominal masses not confirmed and followed by imaging techniques
• Cystic lesions
• Must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen (unless there is a contraindication) if tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization [FISH])
• No CNS metastasis unless controlled by prior surgery and/or radiotherapy
• "Controlled" is defined as ≥ 2 months of no symptoms or evidence of progression
• Currently enrolled on clinical trial QOL N0392
• Hormone receptor status not specified
• Hormone-positive tumor must meet at least 1 of the following criteria:
• Tumor refractory to hormonal therapy
• Heavy visceral tumor burden that requires chemotherapy for better and faster control of metastatic disease
• Relapsed disease during adjuvant hormonal therapy and failed first-line chemotherapy
• Not treated with hormonal therapy because of side effects or adverse events

PATIENT CHARACTERISTICS:

• Male or female
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Platelet count ≥ 100,000/mm^3
• Hemoglobin > 8.0 g/dL
• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:
• AP normal AND AST and ALT ≤ 5 times ULN
• AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST and ALT normal
• Creatinine clearance ≥ 30 mL/min
• Serum sodium normal
• Not pregnant or nursing
• No nursing during and for 30 days after completion of study therapy
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study therapy
• No history of allergy or hypersensitivity to drug product excipients or to agents chemically similar to vinflunine and/or capecitabine
• No prior unanticipated severe reaction to fluoropyrimidine therapy
• No known hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No active, unresolved infection
• No New York Heart Association class III-IV cardiovascular disease, unstable angina, myocardial infarction within the past 6 months, or poorly controlled hypertension
• No preexisting neuropathy ≥ grade 2
• No concurrent serious medical condition that would preclude study treatment
• No other stage III or IV invasive cancer within the past 3 years
• No lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication
• Ability to complete questionnaires alone or with assistance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior unlimited hormonal therapy allowed in the neoadjuvant, adjuvant, or metastatic setting
• No major surgery, chemotherapy, or immunologic therapy within the past 4 weeks
• No radiotherapy within the past 4 weeks, except if to a nontarget lesion only
• Prior radiotherapy to a target lesion is allowed if there has been clear progression of the lesion since radiotherapy was completed
• If patient received single-dose radiotherapy or palliation to a nontarget lesion only, the patient may immediately proceed to study registration without waiting 4 weeks
• No prior fluoropyrimidines, including capecitabine, or vinca alkaloids (e.g., vinorelbine, vinblastine, vincristine, or vindesine) for metastatic breast cancer
• No prior radiotherapy to > 30% of bone marrow-containing areas
• No cimetidine, allopurinol, sorivudine, or brivudine within the past 2 weeks
• No ketoconazole, itraconazole, ritonavir, amprenavir, or indinavir within the past 2 weeks
• No concurrent treatment in another clinical trial in which investigational procedures are performed or investigational therapies are administered
• No concurrent trastuzumab (Herceptin®)
• No concurrent hormonal therapy
• No concurrent interleukin-11
• No other concurrent chemotherapeutic agents, biologic agents, or radiotherapy
• No concurrent administration of any of the following:
• Cimetidine
• Allopurinol
• Sorivudine
• Brivudine
• Ketoconazole
• Itraconazole
• Ritonavir
• Amprenavir
• Indinavir
• Warfarin allowed if patient is on a stable dose and has an INR < 3.0