Clinical trial NCT00290719 (phase 1, status: terminated)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: cisplatin, gefitinib, irinotecan hydrochloride
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Reason stopped: 
    low enrollment
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the
             esophagus

               -  AC of the gastroesophageal junction allowed

          -  Tumor must be considered surgically resectable (T1-3, NX)

               -  No early-stage cancer (T1, N0)

          -  The following lymph node (LN) criteria are considered acceptable:

               -  Regional thoracic LN metastases (N1)

               -  LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan

               -  Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by
                  CT scan

          -  No distant metastases (M0)

        PATIENT CHARACTERISTICS:

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Creatinine clearance ≥ 50 mL/min

          -  Creatinine serum level ≤ CTC grade 2

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST < 3 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

          -  No known severe hypersensitivity to gefitinib or any of its excipients

          -  No evidence (except asymptomatic chronic stable radiographic changes) of clinically
             active interstitial lung disease

          -  No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable
             angina

          -  No New York Heart Association class III or IV heart disease

          -  No other concurrent malignancies or malignancies diagnosed within the past 5 years
             except basal cell carcinoma or carcinoma in situ of the cervix

          -  No serious active or uncontrolled infection, systemic disease, psychiatric illness, or
             other medical condition that would preclude study participation

          -  No evidence of any significant clinical disorder or laboratory finding that would
             preclude study participation

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for esophageal cancer

          -  No prior radiotherapy that would overlap the study treatment fields

          -  Recovered from prior major surgery

          -  No nonapproved or investigational drugs within the past 30 days

          -  No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or
             Hypericum perforatum (St. John's wort)