Radiation Therapy, Pemetrexed Disodium, and Carboplatin in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed By Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: carboplatin; Pemetrexed; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention description: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.; Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.; Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus; stage III esophageal cancer; stage II esophageal cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving radiation therapy together with pemetrexed disodium and
      carboplatin before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed.

      PURPOSE: This phase II trial is studying how well giving radiation therapy together with
      pemetrexed disodium and carboplatin works in treating patients with locally advanced
      esophageal cancer that can be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of
             the esophagus or gastroesophageal (GE) junction

               -  No T1-2, N0, M0 disease

               -  No palpable or biopsy-proven involvement of supraclavicular nodes or
                  radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension)
                  for lesions in mid-thoracic, distal thoracic, or GE junction

                  + Supraclavicular node involvement allowed provided there are upper thoracic
                  esophagus primary lesions

               -  Patients with involvement of celiac nodes (stations 15-20) are eligible if the
                  primary lesion is mid-thoracic, distal esophagus, or GE junction

               -  No evidence of distant metastases

          -  Tumor must be considered surgically resectable

             - Patients with T4, N0 tumors that are potentially resectable are eligible

          -  No clinically relevant pleural or peritoneal effusion that is not amenable to drainage

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count ≥1,500/mm^3

          -  Platelet count ≥100,000/mm^3

          -  Hemoglobin ≥10 g/dL

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST ≤ 3 times ULN

          -  Creatinine clearance ≥ 45 mL/min

          -  No New York Heart Association class III or IV congestive heart failure

          -  Pregnant or nursing women are ineligible

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No uncontrolled infection

          -  No other severe underlying disease that would preclude study entry

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ

          -  No prior sensitivity or allergic reaction to pemetrexed disodium or carboplatin

          -  Able to swallow pills

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy for esophageal cancer

          -  No prior radiotherapy field that overlapped the anticipated fields of study
             radiotherapy

          -  No prior radiotherapy to > 30% of the marrow cavity

          -  Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) must be able to
             discontinue use 2 days prior, during, and 2 days after pemetrexed disodium
             administration (5 days prior for long-life NSAIDs)

          -  Patients must not have been receiving cyclooxygenase-2 inhibitors at study entry and
             while receiving protocol therapy