Ixabepilone and Pemetrexed/Solid Tumors

Inclusion Criteria:

• SWOG performance status of 0-2.
• Projected life expectancy of at least 3 months.
• Female and or male age 18 years and over.
• Provision of informed consent prior to any study-related procedures.
• Female patients must not be pregnant due to the potential mutagenicity. and teratogenicity of this treatment. A pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential.
• Negative pregnancy test for women of childbearing potential.
• Patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study. Sexually active males must also use a reliable and appropriate method of contraception. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
• Patients must have recovered from acute toxicities from previous surgery, chemotherapy or radiation therapy.

• Adequate organ function defined as:

  • ANC > 1500/mm3
  • Platelet count > 100,000 cells/mm3
  • Hemoglobin > 9.0g/dL
  • Serum creatinine < 1.5 mg/dl or creatinine clearance > 45 mL/minute
  • (calculated by Cockcroft-Gault formula.)
  • Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal. In patients with bone metastasis and no evidence of liver metastasis and bilirubin < upper limit of normal an alkaline phosphatase < 5 ULN will be allowed
  • Serum Bilirubin < 1.5 mg/dL
• Peripheral neuropathy grade 0-1.
• No other concomitant therapy directed at the cancer is allowed.
• The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.
• The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

• Laboratory results:

  • Serum bilirubin > 1.5 the upper limit of reference range (ULRR)
  • Serum creatinine >1.5 x ULRR or creatinine clearance < 45 mL/minute (calculated by Cockcroft-Gault formula)
• Women who are currently pregnant or breast feeding.
• Receipt of any investigational agents within 30 days prior to commencing study treatment.
• Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy.
• Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
• Prior radiation must not have included ≥ 30% of major bone marrow containing areas (pelvis, lumbar spine).
• Any unresolved toxicity greater than CTC grade 1 from previous anti- cancer therapy, excluding alopecia.
• CTC Grade 1 or greater neuropathy (motor or sensory) at study entry.
• Hematologic function with absolute neutrophils ≤ 1500/mm3 and/or platelets < 100,000/mm 3.
• Hepatic function with serum bilirubin greater than the upper institutional limits of normal, ALT and AST > 2.5 times the upper institutional limits of normal.
• Presence of third space fluid which cannot be controlled by drainage.