Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Docetaxel; Oxaliplatin

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