Avastin and Taxotere for Esophagogastric Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine what effects (good and bad) bevacizumab (Avastin) and docetaxel (Taxotere), used in combination, have on metastatic gastric and esophageal cancer.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Genentech, Inc.; Massachusetts General Hospital; Sanofi
• Treatments: Bevacizumab; Docetaxel

Criteria

Inclusion Criteria:

• Histologically confirmed, unresectable or metastatic stage IV esophageal or gastric carcinoma

• Measurable disease greater than or equal to 1cm by spiral computed tomography (CT) scan or greater than or equal to 2cm by other radiographic technique

• ECOG performance status 0-2

• One prior chemotherapy for metastatic disease permitted

• White blood cell count greater than or equal to 3,000/mm

• Absolute neutrophil count greater than or equal to 1,500/mm3

• Platelet count greater than or equal to 100,000/mm3

• Hemoglobin greater than or equal to 8.0g/dl

• Creatinine less than 2.0mg/dL

• Total bilirubin less than 1.9mg/dL

Exclusion Criteria:

• Pregnant or lactating women

• History or evidence of central nervous system (CNS) disease

• Other active malignancies other than non-melanoma skin cancer or in-situ cervical cancer

• History of severe hypersensitivity to docetaxel, bevacizumab or drugs formulated with polysorbate 80.

• Current, recent or planned treatment with standard chemotherapy, radiation therapy or another experimental therapy.

• History of other disease or metabolic dysfunction.

• Serious, non-healing wound, ulcer, or bone fracture.