Avastin and Taxotere for Esophagogastric Cancer

Phase 2

Completed

• Conditions: Esophageal Cancer; Gastric Cancer

• Registration Number: NCT00137813
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Primary Completion: 2006-09
• Study Completion: 2009-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer	3 years

Secondary Outcome Measures

Name	Time	Method
To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States