Trial · NCT01208103

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

NCT01208103, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma. Trials, record NCT01208103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208103

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
NCT number: NCT01208103
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
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: Bevacizumab, Capecitabine, Oxaliplatin
First posted: 2010-09-23
Last updated: 2020-09-03
Results first posted: 2020-01-18

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Progression-free Survival (PFS) at Six Months	6 months	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.
Secondary	To Determine the Response Rate (RR) for CAPOX and Bevacizumab	39 months	Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
Secondary	To Determine the Overall PFS for CAPOX and Bevacizumab	39 months	Time interval in months from date of first treatment until the date of first documented progression
Secondary	To Determine the Overall Survival (OS) for CAPOX and Bevacizumab	39 months	The length of time interval in months from date of first treatment until the date of death or lost follow-up
Secondary	Number of Participants With Adverse Events	39 months	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Progression-free Survival (PFS) at Six Months	6 months	percentage of participants	NUMBER
SECONDARY	To Determine the Response Rate (RR) for CAPOX and Bevacizumab	39 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	To Determine the Overall PFS for CAPOX and Bevacizumab	39 months	months	MEDIAN
SECONDARY	To Determine the Overall Survival (OS) for CAPOX and Bevacizumab	39 months	months	MEDIAN
SECONDARY	Number of Participants With Adverse Events	39 months	participants	NUMBER

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Progression-free Survival (PFS) at Six Months	Bevacizumab + Capecitabine + Oxaliplatin		68	95% Confidence Interval 52 to 88	percentage of participants
To Determine the Response Rate (RR) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin	Complete Response	1		Participants
To Determine the Response Rate (RR) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin	Partial Response	13		Participants
To Determine the Response Rate (RR) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin	Stable Disease	10		Participants
To Determine the Response Rate (RR) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin	Progressive Disease	5		Participants
To Determine the Response Rate (RR) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin	Unevaluable	1		Participants
To Determine the Overall PFS for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin		8.7	95% Confidence Interval 4.9 to 10.5	months
To Determine the Overall Survival (OS) for CAPOX and Bevacizumab	Bevacizumab + Capecitabine + Oxaliplatin		12.9	95% Confidence Interval 9.2 to 19.7	months
Number of Participants With Adverse Events	Bevacizumab + Capecitabine + Oxaliplatin		30		participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bevacizumab + Capecitabine + Oxaliplatin	30
Overall Study	COMPLETED	Bevacizumab + Capecitabine + Oxaliplatin	28
Overall Study	NOT COMPLETED	Bevacizumab + Capecitabine + Oxaliplatin	2

Source ClinicalTrials.gov

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Bevacizumab + Capecitabine + Oxaliplatin	17	30
other	Platelet count decreased	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	14	30
other	Neutrophil count decreased	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	11	30
other	Abdominal pain	Gastrointestinal disorders	Bevacizumab + Capecitabine + Oxaliplatin	7	30
other	Alanine aminotransferase increased	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	16	30
other	Alkaline phosphatase increased	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	7	30
other	Anorexia	Metabolism and nutrition disorders	Bevacizumab + Capecitabine + Oxaliplatin	23	30
other	Ascites	Gastrointestinal disorders	Bevacizumab + Capecitabine + Oxaliplatin	1	30
other	Aspartate	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	21	30
other	Blood bilirubin increased	Investigations	Bevacizumab + Capecitabine + Oxaliplatin	6	30

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bevacizumab + Capecitabine + Oxaliplatin	30	30
Total, other adverse events	Bevacizumab + Capecitabine + Oxaliplatin	30	30
Total, serious adverse events	Bevacizumab + Capecitabine + Oxaliplatin	4	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01208103

GET https://conductscience.org/api/trials/v1/NCT01208103/events?page=2

API reference For AI assistants