Trial Outcomes & Findings for Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma (NCT NCT01208103)
NCT ID: NCT01208103
Last Updated: 2020-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2020-09-03
Participant Flow
August 2011 to November 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
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 Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
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 Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsA 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.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
Number of Participants With Progression-free Survival (PFS) at Six Months
|
68 percentage of participants
Interval 52.0 to 88.0
|
SECONDARY outcome
Timeframe: 39 monthsComplete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Complete Response
|
1 Participants
|
|
To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Partial Response
|
13 Participants
|
|
To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Stable Disease
|
10 Participants
|
|
To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Progressive Disease
|
5 Participants
|
|
To Determine the Response Rate (RR) for CAPOX and Bevacizumab
Unevaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: 39 monthsTime interval in months from date of first treatment until the date of first documented progression
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
To Determine the Overall PFS for CAPOX and Bevacizumab
|
8.7 months
Interval 4.9 to 10.5
|
SECONDARY outcome
Timeframe: 39 monthsThe length of time interval in months from date of first treatment until the date of death or lost follow-up
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
To Determine the Overall Survival (OS) for CAPOX and Bevacizumab
|
12.9 months
Interval 9.2 to 19.7
|
SECONDARY outcome
Timeframe: 39 monthsToxicity 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.
Outcome measures
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events
|
30 participants
|
Adverse Events
Bevacizumab + Capecitabine + Oxaliplatin
Serious events: 4 serious events
Other events: 30 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.3%
1/30 • Assessed up to 67 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Assessed up to 67 months
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Assessed up to 67 months
|
Other adverse events
| Measure |
Bevacizumab + Capecitabine + Oxaliplatin
n=30 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
56.7%
17/30 • Assessed up to 67 months
|
|
Investigations
Platelet count decreased
|
46.7%
14/30 • Assessed up to 67 months
|
|
Investigations
Neutrophil count decreased
|
36.7%
11/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.3%
7/30 • Assessed up to 67 months
|
|
Investigations
Alanine aminotransferase increased
|
53.3%
16/30 • Assessed up to 67 months
|
|
Investigations
Alkaline phosphatase increased
|
23.3%
7/30 • Assessed up to 67 months
|
|
Metabolism and nutrition disorders
Anorexia
|
76.7%
23/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Ascites
|
3.3%
1/30 • Assessed up to 67 months
|
|
Investigations
Aspartate
|
70.0%
21/30 • Assessed up to 67 months
|
|
Investigations
Blood bilirubin increased
|
20.0%
6/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Assessed up to 67 months
|
|
Investigations
Creatinine increased
|
6.7%
2/30 • Assessed up to 67 months
|
|
Metabolism and nutrition disorders
Dehydration
|
36.7%
11/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Diarrhea
|
76.7%
23/30 • Assessed up to 67 months
|
|
Nervous system disorders
Dysesthesia
|
86.7%
26/30 • Assessed up to 67 months
|
|
General disorders
Fatigue
|
80.0%
24/30 • Assessed up to 67 months
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Assessed up to 67 months
|
|
Vascular disorders
Hypertension
|
36.7%
11/30 • Assessed up to 67 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
3/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Nausea
|
76.7%
23/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30 • Assessed up to 67 months
|
|
Nervous system disorders
Peripheral sensor neuropathy
|
76.7%
23/30 • Assessed up to 67 months
|
|
Respiratory, thoracic and mediastinal disorders
Pnuemonitis
|
3.3%
1/30 • Assessed up to 67 months
|
|
Hepatobiliary disorders
Portal hypertension
|
3.3%
1/30 • Assessed up to 67 months
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
12/30 • Assessed up to 67 months
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Assessed up to 67 months
|
|
Vascular disorders
Thromboembolic event
|
3.3%
1/30 • Assessed up to 67 months
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
16/30 • Assessed up to 67 months
|
|
Investigations
Weight loss
|
23.3%
7/30 • Assessed up to 67 months
|
Additional Information
Dr. Michael Overman/Gastrointestinal Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-745-4317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place