Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of advanced or recurrent solid tumors
• •* Patients for whom docetaxel is considered appropriate anticancer therapy; docetaxel is currently approved for use in patients with the following solid tumors:
• •* Non-small cell lung (NSCLC)
• •* Breast
• •* Prostate
• •* Esophageal
• •* Head and neck
• •* Ovarian
• •* Gastric
• •Measurable or non-measurable disease
• •No squamous cell NSCLC
• •Controlled brain metastases allowed
• •* Clinically stable with no signs of progression by MRI or CAT scan ≥ 60 days after treatment
• •* Patients must be asymptomatic with no steroid requirements
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •Life expectancy ≥ 12 weeks
• •WBC ≥ 3,000/mm\^3\*
• •ANC ≥ 1,500/mm\^3\*
• •Hemoglobin ≥ 9 g/dL
• •Platelet count ≥ 100,000/mm\^3
• •Total bilirubin normal
• •AST, ALT, and alkaline phosphatase (AP) must meet one of the following criteria:
• •* AST or ALT ≤ 3\*\* times upper limit of normal (ULN) AND AP normal
• •* AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
• •* AST or ALT normal AND AP ≤ 5 times ULN
• •Calculated creatinine clearance ≥ 45 mL/min OR GFR measured by Tc99m-DPTA serum clearance method
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• •Able to interrupt aspirin or other NSAIDs pre- and post- twice-monthly drug dosing
• •Able to take folic acid, vitamin B12, or corticosteroids
• •No uncontrolled serious active infections
• •No pre-existing peripheral neuropathy \> grade 1
• •No significant cardiac disease (i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure within the past 6 months, LVEF \< normal, myocardial infarction within the past year, or serious cardiac arrhythmias requiring medication)
• •No known severe hypersensitivity reaction to docetaxel or other drugs formulated in polysorbate 80 NOTE: \*No concurrent colony-stimulating factors to maintain these values
• •NOTE: \*\*For patients with liver metastases, AST or ALT ≤ 5 times ULN AND AP normal
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Have received 0-1 prior systemic therapy regimens (prior adjuvant chemotherapy will be considered a prior systemic therapy regimen)
• •At least 4 weeks since prior systemic anticancer therapy (6 weeks for mitomycin C and nitrosoureas)
• •At least 2 weeks since prior radiotherapy and recovered from the side effects to ≤ grade 1
• •At least 2 weeks since prior pleurodesis
• •No concurrent radiotherapy