Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, adenocarcinoma of the stomach
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
Sites / Locations
- University of Michigan Comprehensive Cancer Center
- Barbara Ann Karmanos Cancer Institute
- Veterans Affairs Medical Center - Detroit
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Docetaxel, Oxaliplatin & Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.