Avastin and Taxotere for Esophagogastric Cancer

Tracking Information
First Submitted Date ICMJE	August 29, 2005
First Posted Date ICMJE	August 30, 2005
Last Update Posted Date	May 10, 2016
Study Start Date ICMJE	August 2004
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 19, 2007)	To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer [ Time Frame: 3 years ]
Original Primary Outcome Measures ICMJE; (submitted: August 29, 2005)	To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer.
Change History	Complete list of historical versions of study NCT00137813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 28, 2005)	To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab
Original Secondary Outcome Measures ICMJE; (submitted: August 29, 2005)	To evaluate the duration of response, progression-free and overall survival of patients with esophageal or gastric cancer treated with docetaxel and bevacizumab.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Avastin and Taxotere for Esophagogastric Cancer
Official Title ICMJE	Phase II Study of Bevacizumab and Docetaxel (AvaTax) in Metastatic Esophagogastric Cancer
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Esophageal Cancer; Gastric Cancer
Intervention ICMJE	Drug: Docetaxel Given intravenously once a week for 3 out of four weeks for a minimum of 8 weeks and maximum of a year and a half Other Name: AvaTax; Drug: Bevacizumab Given intravenously once a week for every other week for a minimum of 8 weeks and a maximum of a year and a half
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: December 19, 2007)	42
Original Enrollment ICMJE; (submitted: August 29, 2005)	39
Estimated Study Completion Date	July 2016
Actual Primary Completion Date	September 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00137813
Other Study ID Numbers ICMJE	04-179
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Peter C. Enzinger, MD, Dana-Farber Cancer Institute
Study Sponsor ICMJE	Dana-Farber Cancer Institute
Collaborators ICMJE	Brigham and Women's Hospital; Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Genentech, Inc.; Sanofi
Investigators ICMJE	Principal Investigator: Peter Enzinger, MD Dana-Farber Cancer Institute
PRS Account	Dana-Farber Cancer Institute
Verification Date	May 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP