Clinical trial NCT00217581 (phase 2, status: completed)
Conditions: esophageal cancer, gastric cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: docetaxel, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed gastric or gastroesophageal junction adenocarcinoma

               -  Locally advanced unresectable or metastatic disease

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10mm by spiral CT scan

               -  Bone metastases, ascites, or pleural effusions are not considered measurable
                  disease

               -  Evaluable disease must be present outside previously irradiated field

          -  No CNS or brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  SWOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 mg/dL

          -  No evidence of bleeding diathesis or coagulopathy

        Hepatic

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Bilirubin ≤ ULN

          -  INR < 1.5

        Renal

          -  Creatinine < 2.0 mg/dL

          -  Urine protein:creatinine ratio < 1.0

        Cardiovascular

          -  No history of deep venous thrombosis requiring anticoagulation

          -  No active angina

          -  No myocardial infarction within the past year

          -  No cerebrovascular accident within the past year

          -  No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or
             diastolic BP > 100 mm Hg) despite medical management

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

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

          -  No peripheral neuropathy > grade 1

          -  No history of allergy to any of the study drugs or drugs formulated with polysorbate
             80

          -  No known HIV infection

          -  No active peptic ulcer disease

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No unresolved bacterial infection requiring antibiotics

          -  No other active malignancy within the past 3 years except for cancers that have been
             treated with a curative intent

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent immunotherapy

        Chemotherapy

          -  No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after
             completion of non-taxane adjuvant chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  At least 3 weeks since radiotherapy

        Surgery

          -  At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter
             placement)

          -  No concurrent surgery

        Other

          -  At least 4 weeks since prior and no concurrent participation in another experimental
             drug trial

          -  No concurrent full-dose anticoagulation

          -  No concurrent experimental drugs