Avastin and Taxotere for Esophagogastric Cancer

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: Docetaxel; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00137813

04-179

Details and patient eligibility

About

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.

Full description

Bevacizumab will be administered intravenously in an outpatient clinic once a week, every other week. Docetaxel will also be administered intravenously in the outpatient clinic once a week for three out of four weeks. Blood tests and vital signs will be performed weekly.

After the first eight weeks of therapy a CT scan will be performed to determine and assess the progress of the disease. If therapy is continued, radiological procedures will be performed at week 16 and every 8 weeks thereafter.

Treatment will be given for a minimum of 8 weeks, as long as the patient does not experience unacceptable side effects. Chemotherapy will continue for a year and a half as long as the cancer is responding and there are no unacceptable side effects.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)