Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer

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