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