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Home > "C" Clinical Trials Conditions > Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer  Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Not yet recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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. Combining capecitabine with tipifarnib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining capecitabine with tipifarnib in treating women who have taxane-resistantmetastatic breast cancer.
Details: OBJECTIVES: Primary - Determine the response rate in women with taxane-resistant metastatic breast cancer treated with capecitabine and tipifarnib. Secondary - Determine the toxicity of this regimen in these patients. - Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 7 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamGradishar, Study Chair, Robert H. Lurie Cancer Center
Additional Information:
Study ID Numbers: CDR0000350219; ECOG-E1103
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077363
Other Recurrent Breast Cancer Studies:
1. Bexarotene in Treating Patients With Metastatic Breast Cancer
2. Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer
3. Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel
4. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
5. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
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Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
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