Gemcitabine and Pemetrexed Disodium in Treating Patients With Advanced Mycosis Fungoides or Sézary Syndrome

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed\* mycosis fungoides or Sézary syndrome
• •* Stage IB-IVB disease NOTE: \*Pathology report must read diagnostic or consistent with mycosis fungoides/Sézary syndrome
• •Failed ≥ 1 prior systemic treatment
• •Measurable disease
• •* At least 1 indicator lesion must be designated prior to study entry
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Life expectancy ≥ 6 months
• •Creatinine ≤ 2.0 mg/dL
• •Creatinine clearance ≥ 45 mL/min
• •Bilirubin ≤ 2.2 mg/dL
• •AST and ALT ≤ 2 times upper limit of normal
• •WBC ≥ 3,000/mm³
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •No acute infection requiring systemic treatment
• •No history of severe hypersensitivity reaction to the study drugs or to any other ingredient used in their formulation
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •At least 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy
• •No acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) for 2 days before and for 2 days after pemetrexed disodium infusion (5 days before and for 2 days after pemetrexed disodium infusion for patients taking NSAIDs with a long half-life \[e.g., naproxen, refocoxib, or celecoxib\])
• •No concurrent topical agents except emollients
• •No other concurrent topical or systemic anticancer therapies
• •No other concurrent investigational agents