This trial is active, not recruiting.

Conditions esophageal cancer, gastric cancer
Treatments docetaxel, bevacizumab
Phase phase 2
Target VEGF
Sponsor Dana-Farber Cancer Institute
Collaborator Brigham and Women's Hospital
Start date August 2004
End date September 2006
Trial size 42 participants
Trial identifier NCT00137813, 04-179


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
time frame: 3 years

Secondary Outcomes

To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
time frame: TBD

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
Principal investigator Peter Enzinger, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.