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Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01208103
Recruitment Status : Completed
First Posted : September 23, 2010
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ampulla of Vater Adenocarcinoma
Small Intestinal Adenocarcinoma
Stage III Ampulla of Vater Cancer AJCC v8
Stage III Small Intestinal Adenocarcinoma AJCC v8
Stage IIIA Ampulla of Vater Cancer AJCC v8
Stage IIIA Small Intestinal Adenocarcinoma AJCC v8
Stage IIIB Ampulla of Vater Cancer AJCC v8
Stage IIIB Small Intestinal Adenocarcinoma AJCC v8
Stage IV Ampulla of Vater Cancer AJCC v8
Stage IV Small Intestinal Adenocarcinoma AJCC v8
Interventions Biological: Bevacizumab
Drug: Capecitabine
Drug: Oxaliplatin
Enrollment 30
Recruitment Details August 2011 to November 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description Capecitabine 750 mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description Capecitabine 750 mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
64
(42 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
18
  60.0%
Male
12
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
3
  10.0%
Not Hispanic or Latino
26
  86.7%
Unknown or Not Reported
1
   3.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  10.0%
White
22
  73.3%
More than one race
0
   0.0%
Unknown or Not Reported
5
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Progression-free Survival (PFS) at Six Months
Hide Description A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
68
(52 to 88)
2.Secondary Outcome
Title To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Hide Description Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   3.3%
Partial Response
13
  43.3%
Stable Disease
10
  33.3%
Progressive Disease
5
  16.7%
Unevaluable
1
   3.3%
3.Secondary Outcome
Title To Determine the Overall PFS for CAPOX and Bevacizumab
Hide Description Time interval in months from date of first treatment until the date of first documented progression
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
8.7
(4.9 to 10.5)
4.Secondary Outcome
Title To Determine the Overall Survival (OS) for CAPOX and Bevacizumab
Hide Description The length of time interval in months from date of first treatment until the date of death or lost follow-up
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
12.9
(9.2 to 19.7)
5.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments.
Time Frame 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description:
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
30
Time Frame Assessed up to 67 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab + Capecitabine + Oxaliplatin
Hide Arm/Group Description Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
All-Cause Mortality
Bevacizumab + Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   30/30 (100.00%) 
Hide Serious Adverse Events
Bevacizumab + Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   4/30 (13.33%) 
Gastrointestinal disorders   
Upper gastrointestinal hemorrhage * 1  1/30 (3.33%) 
Abdominal pain * 1  1/30 (3.33%) 
General disorders   
Non-cardiac chest pain * 1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/30 (3.33%) 
1
Term from vocabulary, CTCAE 4.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.3%
Bevacizumab + Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  17/30 (56.67%) 
Gastrointestinal disorders   
Abdominal pain * 1  7/30 (23.33%) 
Ascites * 1  1/30 (3.33%) 
Colitis * 1  1/30 (3.33%) 
Diarrhea * 1  23/30 (76.67%) 
Nausea * 1  23/30 (76.67%) 
Pancreatitis * 1  1/30 (3.33%) 
Vomiting * 1  16/30 (53.33%) 
General disorders   
Fatigue  1  24/30 (80.00%) 
Hepatobiliary disorders   
Portal hypertension * 1  1/30 (3.33%) 
Investigations   
Platelet count decreased * 1  14/30 (46.67%) 
Neutrophil count decreased * 1  11/30 (36.67%) 
Alanine aminotransferase increased * 1  16/30 (53.33%) 
Alkaline phosphatase increased * 1  7/30 (23.33%) 
Aspartate * 1  21/30 (70.00%) 
Blood bilirubin increased * 1  6/30 (20.00%) 
Creatinine increased * 1  2/30 (6.67%) 
Weight loss * 1  7/30 (23.33%) 
Metabolism and nutrition disorders   
Anorexia * 1  23/30 (76.67%) 
Dehydration * 1  11/30 (36.67%) 
Hyponatremia * 1  3/30 (10.00%) 
Nervous system disorders   
Dysesthesia * 1  26/30 (86.67%) 
Headache * 1  3/30 (10.00%) 
Peripheral sensor neuropathy * 1  23/30 (76.67%) 
Syncope * 1  1/30 (3.33%) 
Renal and urinary disorders   
Proteinuria * 1  12/30 (40.00%) 
Respiratory, thoracic and mediastinal disorders   
Pnuemonitis * 1  1/30 (3.33%) 
Vascular disorders   
Hypertension * 1  11/30 (36.67%) 
Thromboembolic event * 1  1/30 (3.33%) 
1
Term from vocabulary, CTCAE 4.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Overman/Gastrointestinal Medical Oncology
Organization: UT MD Anderson Cancer Center
Phone: 713-745-4317
EMail: MOverman@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01208103    
Other Study ID Numbers: 2009-0626
NCI-2018-01828 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-2011-00470
2009-0626 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2010
First Posted: September 23, 2010
Results First Submitted: November 5, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020