Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Intervention: pralatrexate; fluorouracil; laboratory biomarker analysis; DNA analysis; high performance liquid chromatography; polymerase chain reaction; nucleic acid sequencing; pharmacological study; pharmacogenomic studies; polymorphism analysis
Intervention description: Given IV; Given IV; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Fluorouracil
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving pralatrexate together with fluorouracil may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of pralatrexate when
      given together with fluorouracil in treating patients with recurrent solid tumors
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cancer patients who have failed standard therapy for their disease or for whom no such
             therapy is available are eligible, for which 5-fluoropyrimdines, including 5-FU, or
             inhibitors of DHFR (dihydrofolate reductase), including pralatrexate, have the
             potential for therapeutic benefit

          -  Objectively measurable disease is preferred, but not required

          -  Performance status of 0-2 (Eastern Cooperative Oncology Group [ECOG])

          -  Prior treatment:

          -  The patient should have recovered from the toxicities associated with prior
             chemotherapy (at least 3 weeks from prior therapy)

          -  At least two or more weeks should have elapsed since any radiotherapy, and the patient
             should have recovered from the toxicity associated with such therapy

          -  If a recent surgical procedure has been performed, the patient should have recovered
             from the surgery prior to entering this trial

          -  Absolute granulocyte count of 1500 per mcL or greater

          -  Platelet count of 100,000 per mcL or greater

          -  Serum bilirubin less than 1.5 times the upper limits of the institutional normal

          -  Serum creatinine less than the upper limits of normal

          -  The patient must willingly give signed informed consent

        Exclusion Criteria:

          -  Pregnant women and nursing mothers are ineligible; eligible patients of reproductive
             potential should use adequate contraception if sexually active

          -  Serious concurrent medical illness which would jeopardize the ability of the patient
             to receive the chemotherapy program outlined in this protocol with reasonable safety

          -  Patients with active infections requiring intravenous antibiotic therapy are not
             eligible until the infection has resolved

          -  Patients who are human immunodeficiency virus (HIV) antibody positive and are
             receiving highly active antiretroviral therapy (HAART) are ineligible

          -  Concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and
             trimethoprim/sulfamethoxazole will not be allowed