Bevacizumab With Capecitabine and Oxaliplatin in Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
|ClinicalTrials.gov Identifier: NCT01208103|
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancers||Drug: Capecitabine Drug: Oxaliplatin Drug: Bevacizumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater|
|Actual Study Start Date :||May 6, 2011|
|Actual Primary Completion Date :||March 7, 2018|
|Actual Study Completion Date :||March 7, 2018|
Experimental: Bevacizumab, Capecitabine, Oxaliplatin
Bevacizumab 7.5 mg/kg by vein on day 1 over 90 minutes of 21 day cycle. Capecitabine 750 mg/m2 by mouth twice a day beginning on day 1-14 of 21 day cycle. Oxaliplatin 130 mg/m2 by vein on day 1 over 2 hours of 21 day cycle.
750 mg/m2 by mouth twice a day beginning on day 1-14 of 21 day cycle.
Other Name: XelodaDrug: Oxaliplatin
130 mg/m2 by vein on day 1 over 2 hours of 21 day cycle.
Other Name: EloxatinDrug: Bevacizumab
7.5 mg/kg by vein on day 1 over 90 minutes of 21 day cycle.
- Number of Patients with Progression-Free Survival (PFS) [ Time Frame: 6 months ]PFS defined as from date of treatment start to date of first documentation of progression or symptomatic deterioration or death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208103
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Overman, MD||M.D. Anderson Cancer Center|