- 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
- 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
- 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.
- 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
- Last dose of prior chemotherapy discontinued less than 4 weeks before the start of
- 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,
- CTC Grade 1 or greater neuropathy (motor or sensory) at study entry.
- Hematologic function with absolute neutrophils ≤ 1500/mm3 and/or platelets <
- 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.