Pemetrexed, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: pemetrexed disodium; Radiotherapy
Intervention description: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy).; During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).
Intervention MeSH terms: Pemetrexed
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes
      needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high energy x-rays to kill tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when
      given together with radiation therapy in treating patients with locally advanced pancreatic
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed carcinoma arising from the pancreas

               -  Stage II or III disease, meeting 1 of the following criteria:

                    -  Nonresectable disease

                    -  Potentially resectable disease

                    -  Resectable disease

               -  Stage IV disease with symptomatic back pain requiring palliation allowed at the
                  discretion of the principal investigator

          -  Measurable, evaluable, or nonmeasurable disease

          -  No neuroendocrine tumor of the pancreas

          -  No documented brain metastasis

          -  No clinically significant pleural or peritoneal effusions that cannot be drained

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

          -  AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

          -  Creatinine clearance ≥ 45 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No active infection

          -  No serious systemic disorders that would preclude study treatment

          -  No significant cardiovascular disease in the form of abnormal electrocardiogram
             coupled with clinical features of recent or recurrent cardiac disease (including
             myocardial infarction, angina, or hypertension)

        PRIOR CONCURRENT THERAPY:

          -  More than 4 weeks since prior investigational agents

          -  No prior chemotherapy for pancreatic cancer

          -  Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal
             anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed
             disodium dose (5 days before for long-acting agents such as piroxicam)

          -  Must be able and willing to take folic acid and cyanocobalamin (vitamin B12)
             supplementation