Clinical trial NCT00238407 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: docetaxel and cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed esophageal cancer, including the gastroesophageal junction

               -  Squamous cell or adenocarcinoma

               -  Unresectable disease

          -  Meets 1 of the following staging criteria by endoscopic ultrasound:

               -  Cervical (supraclavicular) lesion, meeting 1 of the following stages:

                    -  TX, N+ disease

                    -  T3-4, NX disease

                    -  TX, NX, M1a* disease

               -  Thoracic (celiac) lesion, meeting 1 of the following stages:

                    -  Unresectable T4, NX disease

                    -  TX, NX, M1a* disease

               -  Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a
                  requires unequivocal abnormality on staging CT scan/endosonography

          -  No T1-2, N0 disease

          -  All tumors encompassable in 1 radiation field

          -  No tumor with esophagotracheal fistula

        PATIENT CHARACTERISTICS:

        Performance status

          -  WHO 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  AST ≤ 1.5 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Alkaline phosphatase ≤ 2.5 times ULN

        Renal

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  No myocardial infarction within the past 3 months

          -  No New York Heart Association class III or IV congestive heart failure

          -  No unstable angina pectoris

          -  No significant arrhythmias

          -  No other severe cardiovascular disease

        Immunologic

          -  No uncontrolled active infection

          -  No active autoimmune disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 12 months after
             completion of study treatment

          -  No definite contraindication to corticosteroids

          -  No uncontrolled diabetes mellitus

          -  No pre-existing peripheral neuropathy > grade 1

          -  No significant neurologic or psychiatric disorder, including psychotic disorders,
             dementia, or seizures, that would preclude giving informed consent

          -  No other serious underlying medical condition that would preclude study participation

          -  No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately
             treated carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  No prior chemotherapy

        Radiotherapy

          -  No prior radiotherapy to the chest

        Other

          -  More than 30 days since prior experimental treatment in another clinical trial

          -  No other concurrent experimental drugs