Avastin and Taxotere for Esophagogastric Cancer
This trial is active, not recruiting.
|Conditions||esophageal cancer, gastric cancer|
|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|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer
time frame: 3 years
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
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.
|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.|
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