Avastin and Taxotere for Esophagogastric Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00137813 |
Recruitment Status :
Completed
First Posted : August 30, 2005
Last Update Posted : November 1, 2018
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | August 29, 2005 | |||
First Posted Date ICMJE | August 30, 2005 | |||
Last Update Posted Date | November 1, 2018 | |||
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 |
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 |
To evaluate the overall response and safety of the combination docetaxel and bevacizumab in patients with esophageal or gastric cancer. | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 |
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 Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | 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 ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE | 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 | Completed | |||
Actual Enrollment ICMJE |
42 | |||
Original Enrollment ICMJE |
39 | |||
Actual Study Completion Date ICMJE | September 2009 | |||
Actual Primary Completion Date | September 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | 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 ICMJE | Not Provided | |||
Responsible Party | Peter C. Enzinger, MD, Dana-Farber Cancer Institute | |||
Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | October 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |