Clinical trial NCT00268437 (phase 2, status: terminated)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: carboplatin, pemetrexed
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    trial closed early because, during an interim analysis, the primary endpoint fell short.
  
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