Clinical trial NCT00258323 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: cisplatin, fluorouracil, iressa
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or
             large cell undifferentiated cancer of the esophagus or gastroesophageal junction

               -  T3, N1, or M1a disease only

               -  The following types are not allowed:

                    -  Small cell undifferentiated carcinomas, lymphomas, or sarcomas

                    -  Small cell or mixed small cell/non-small cell histology

          -  No evidence of distant hematogenous tumor metastases (M1b)

          -  No malignant pleural effusions

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  WBC > 3,500/mm^3

          -  Platelet count > 100,000/mm^3

        Hepatic

          -  Alkaline phosphatase < 2 times normal

          -  AST < 2 times normal

          -  No unstable or uncompensated hepatic disease

        Renal

          -  Creatinine ≤ 2.0 mg/dL

          -  Calcium normal

          -  No unstable or uncompensated renal disease

        Cardiovascular

          -  No unstable or uncontrolled angina

          -  No unstable or uncompensated cardiac disease

        Pulmonary

          -  See Disease Characteristics

          -  No limitations to pulmonary function that would preclude study participation

          -  No evidence of clinically active interstitial lung disease (asymptomatic patients with
             chronic stable radiographic changes are allowed)

          -  No unstable or uncompensated respiratory disease

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No evidence of severe or uncontrolled systemic disease

          -  No other uncontrolled malignancy

          -  No active infection

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy for this cancer

        Chemotherapy

          -  No prior chemotherapy for this cancer

        Radiotherapy

          -  No prior radiotherapy for this cancer

        Surgery

          -  Recovered from any prior oncologic or other major surgery

          -  No prior surgical resection for this cancer

          -  No concurrent ophthalmic surgery

        Other

          -  No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)

          -  More than 30 days since prior unapproved or investigational drug

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