Status:
COMPLETED
Avastin and Taxotere for Esophagogastric Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00137813
Start Date
August 1 2004
End Date
September 1 2009
Last Update
November 1 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115