Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
Adult Solid Neoplasm, Inflammatory Breast Carcinoma, Male Breast Carcinoma
About this trial
This is an interventional treatment trial for Adult Solid Neoplasm
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed solid tumor Locally advanced or metastatic No known standard therapy that is potentially curative or definitely capable of extending life expectancy No history of metastatic brain disease within the past 6 months Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication Histologically confirmed breast cancer Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis Invasive disease confirmed by 1 of the following*: Incisional biopsy Punch biopsy (applicable for clinical T4b tumors) Core needle (cutting needle) biopsies No distant metastatic disease Hormone receptor status: Not specified Male or female Performance status - ECOG 0-1 Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN AST no greater than 2.5 times ULN Creatinine no greater than 1.25 times ULN Creatinine clearance at least 50 mL/min No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No diabetes No symptomatic neurologic condition No other uncontrolled serious medical condition No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No history of hypersensitivity to intravenous paclitaxel or other medication containing Cremophor EL or polysorbate 80 as a carrier (phase Ib) Phase Ib only: More than 4 weeks since prior immunotherapy More than 4 weeks since prior biologic therapy No concurrent immunotherapy Phase Ib and II: No concurrent prophylactic filgrastim (G-CSF) Phase Ib only: More than 1 year since prior adjuvant docetaxel before metastatic relapse More than 4 weeks since prior chemotherapy and recovered No prior capecitabine AND docetaxel (in combination or as single agents) Prior capecitabine OR docetaxel allowed No other concurrent chemotherapy Phase II only: No prior cytotoxic chemotherapy for breast cancer Phase Ib only: More than 3 weeks since prior radiotherapy No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Phase II only: No prior radiotherapy for breast cancer Phase Ib only: More than 4 weeks since prior major surgery Phase II only: No prior surgery (other than core or incisional biopsy for diagnostic purposes) for breast cancer Phase Ib only: No other ancillary investigational therapy Phase Ib and II: No concurrent sorivudine or brivudine
Sites / Locations
- Mayo Clinic in Arizona
- Howard University Cancer Center CCOP
- Mayo Clinic in Florida
- Barbara Ann Karmanos Cancer Institute
- Mayo Clinic
- Washington University School of Medicine
- University of Wisconsin Medical School
Arms of the Study
Arm 1
Experimental
Treatment (tipifarnib, capecitabine, docetaxel)
Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine.