Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217581
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2005-09-20
Brief Title:
Bevacizumab Oxaliplatin and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial of Bevacizumab Docetaxel and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as oxaliplatin and docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Primary
Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab oxaliplatin and docetaxel
Secondary
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine time to treatment failure and overall survival of patients treated with this regimen
Determine the changes in general and disease-specific quality of life in terms of response to treatment in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes oxaliplatin IV over 120 minutes and docetaxel IV over 60 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study within 18-23 months
Primary
Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab oxaliplatin and docetaxel
Secondary
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine time to treatment failure and overall survival of patients treated with this regimen
Determine the changes in general and disease-specific quality of life in terms of response to treatment in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes oxaliplatin IV over 120 minutes and docetaxel IV over 60 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study within 18-23 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2840 | None | None | None |
| UMCC-2005-052 | None | None | None |
| AVENTIS-WSU-D-2840 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |