Clinical trial NCT00493025 (phase 2, status: terminated)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: cisplatin, gefitinib, paclitaxel
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, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    closed due to early stopping rule-low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
             meeting the following criteria:

               -  Newly diagnosed disease

               -  Surgically resectable tumor

               -  Primary esophageal tumor < 20 cm below the incisors

               -  Tumor extending ≤ 2 cm into the cardia

          -  Stage T2-3, N0-1, M0-1a tumor, as determined by imaging studies and biopsy

               -  Documentation by endoscopic ultrasound, endoscopy, and CT scan of the chest and
                  abdomen required

               -  Any lesion suspicious for metastasis must be biopsied

               -  M1a disease (i.e., celiac nodal metastasis) is allowed if other eligibility
                  criteria are met

               -  T4 disease (i.e., involvement of the pleura, pericardium, or diaphragm) allowed
                  provided it is considered resectable

          -  No CNS metastasis

          -  ECOG performance status 0-1

          -  Granulocyte count > 1,000/mm³

          -  Platelet count > 75,000/mm³

          -  Creatinine clearance > 60 mL/min

          -  Total bilirubin < 1.5 mg/dL

          -  No concurrent illness likely to preclude protocol therapy or surgical resection

          -  Not pregnant or nursing

          -  Negative pregnancy test

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

          -  Known severe hypersensitivity to gefitinib or any of its excipients

          -  Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated
             respiratory, cardiac, hepatic, or renal disease)

          -  Evidence of other significant clinical disorder or laboratory finding that would
             preclude study participation

          -  Evidence of clinically active interstitial lung disease

          -  Chronic, stable radiographic changes that are asymptomatic are eligible

          -  Prior or concurrent malignancy except basal cell or squamous cell skin cancer,
             cervical cancer, or any other curatively treated malignancy from which the patient has
             been disease-free and has a survival prognosis of > 5 years

          -  Preexisting peripheral neuropathy > grade 1

          -  Incomplete healing from prior oncologic or other major surgery

          -  Prior chemotherapy, radiotherapy, or surgery for this cancer

          -  More than 30 days since prior nonapproved or investigational drugs

          -  Concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or
             Hypericum perforatum (St. John's wort)

          -  Concurrent oral retinoids