BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
• Measurable or evaluable disease

• Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD)

  • No biliary tract dilation if radiologically guided biopsy of the liver is planned
  • No requirement for core biopsy of lung lesion that is not pleural based
  • No requirement for laparotomy or thoracotomy solely for biopsy
  • No medical condition that would preclude biopsy
• No known brain metastases
• Performance status - ECOG 0-2
• Performance status - ECOG 0-1 if being treated at the MTD
• More than 3 months
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• No prior bleeding disorder or unexplained bleeding if being treated at the MTD
• Bilirubin no greater than 1.5 mg/dL
• AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• PT/PTT normal
• Creatinine no greater than 1.5 times ULN
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent uncontrolled illness that would preclude study participation
• No ongoing or active infection
• No grade 2 or greater neuropathy (sensory or motor)
• No prior severe allergic reaction attributable to compounds containing Cremophor EL or platinum agents
• No psychiatric illness or social situation that would preclude study compliance
• No medical condition that would preclude study if being treated at the MTD
• At least 4 week since prior immunotherapy
• At least 24 hours since prior growth factors
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No more than 3 prior chemotherapy regimens
• No prior epothilone agents
• At least 1 week since prior hormonal therapy directed at malignancy
• Concurrent hormone replacement therapy allowed
• At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone marrow
• See Disease Characteristics
• At least 4 weeks since prior investigational agents
• No prior or concurrent St. John's Wort
• No concurrent combination anti-retroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No concurrent heparin or other anticoagulants if being treated at the MTD
• No concurrent inhibitors of cytochrome P450 3AP (CYP3A4)