Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Patients must have an incurable advanced or refractory tumor amenable to treatment with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)
• * Per the National Comprehensive Cancer Network, the following cancer sites have been shown to be responsive to taxane therapy:
• * Prostate cancer
• * Breast cancer
• * Non-small cell lung cancer
• * Bladder cancer
• * Head and neck cancer
• * Oral cancer
• * Cervical cancer
• * Ovarian cancer
• * Endometrial cancer
• * Esophageal cancer
• * Gastric cancer
• * Germ cell tumors
• * Tumors of unknown primary
• * Soft tissue sarcomas
• * Small cell lung cancer
• * Testicular cancer
• * Upper genitourinary tract cancers
• PATIENT CHARACTERISTICS:
• Patients must have performance status 0-2 by the ECOG scale
• Absolute neutrophil count ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ institutional upper limit of normal (ULN)
• ALT and AST ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN (if bone metastasis is present in the absence of liver metastasis, alkaline phosphatase must be ≤ 5 x ULN)
• Creatinine ≤ 1.5 x ULN
• Patients must not have baseline sensory neuropathy ≥ grade 2
• Women must not be pregnant or breastfeeding
• Negative blood or urine pregnancy test
• Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception
• PRIOR CONCURRENT THERAPY:
• Prior treatment is allowed, which may include prior taxane therapy
• * If patient has had prior therapy(ies), s/he must have received last treatment ≥ 28 days prior to registration
• Patients must not be receiving colony stimulating factors (CSFs)
• * Previous CSFs must have been discontinued \> 14 days prior to registration
• Patients must not be receiving concomitant treatment with any of the following (prior use is allowed, but must have been discontinued ≥ 28 days prior to registration):
• * Phenytoin
• * Carbamazepine
• * Barbiturates
• * Rifampicin
• * Phenobarbital
• * Hypericum perforatum (St. John's wort)
• * Ketoconazole