500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of
tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together
with tipifarnib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with
tipifarnib works in treating women with taxane-resistant metastatic breast cancer.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Metastatic disease - At least 1 objective measurable disease parameter - No prior radiotherapy to only site of measurable disease - Must have received prior anthracycline therapy (e.g., doxorubicin or epirubicin) in the adjuvant/neoadjuvant setting and/or for metastatic disease - Must have received prior taxane therapy (e.g., paclitaxel or docetaxel) for metastatic disease OR relapsed while receiving adjuvant taxane therapy - Progressive disease during or within 30 days after receiving prior taxane therapy - No prior or concurrent brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Granulocyte count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 3 times ULN (5 times ULN if there is liver involvement by tumor) Renal - Creatinine ≤ 1.5 mg/dL OR - Creatinine clearance ≥ 60 mL/min Cardiovascular - No symptomatic cardiovascular disease Gastrointestinal - No chronic nausea and vomiting - No complete or partial bowel obstruction - No dysphagia or odynophagia with inability to swallow pills Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No greater than grade 1 neuropathy - No ongoing or active infection - No other chronic medical or psychiatric illness that would preclude study participation or compliance - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior capecitabine for metastatic disease - No prior fluorouracil for metastatic disease Endocrine therapy - At least 1 week since prior hormonal therapy in the metastatic or adjuvant/neoadjuvant setting Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Prior radiotherapy to the conserved breast, to the postmastectomy chest wall, or to a limited field involving less than 25% of marrow-containing bone allowed - No other prior radiotherapy - No concurrent radiotherapy Surgery - No prior organ allograft Other - At least 4 weeks since prior cytotoxic drugs - No prior tipifarnib - No other prior farnesyl transferase inhibitors - No prior immunosuppressive therapy - No more than 3 prior cytotoxic regimens for metastatic disease - No concurrent enzyme-inducing anticonvulsant medications (e.g., phenobarbital or phenytoin) - No concurrent warfarin adjusted to an elevated INR - Concurrent prophylactic low-dose warfarin (e.g., 1 mg daily) allowed provided PT and INR are normal
Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 2
Trial ID: NCT00077363
Not Accepting Healthy Volunteers