Trial · NCT00069095

A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

NCT00069095, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-01-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer. Trials, record NCT00069095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00069095

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Trial

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

Title: A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
NCT number: NCT00069095
Status: Completed
Phases: Phase 3
Enrollment: 2,035 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: Colorectal Cancer
Interventions: Oxaliplatin 130 mg/m^2, Capecitabine 1000 mg/m^2, Bevacizumab 7.5 mg/kg, Placebo for bevacizumab 7.5 mg/kg, Oxaliplatin 85 mg/m^2, Leucovorin 200 mg/m^2, Fluorouracil 400 mg/m^2, Bevacizumab 5 mg/kg, Placebo for bevacizumab 5 mg/kg
First posted: 2003-09-18
Last updated: 2016-10-06
Results first posted: 2016-01-22

Source ClinicalTrials.gov

Registered outcomes22

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.
Primary	PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.
Secondary	PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Secondary	PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.
Secondary	PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Secondary	PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Secondary	PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Secondary	PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.
Secondary	Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.
Secondary	Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.	days	MEDIAN
SECONDARY	PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.	days	MEDIAN
SECONDARY	PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	The ITT population included all randomized participants who provided written informed consent.	days	MEDIAN
SECONDARY	PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.	days	MEDIAN
SECONDARY	PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	The ITT population included all randomized participants who provided written informed consent.	days	MEDIAN
SECONDARY	PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.	days	MEDIAN
SECONDARY	PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	The ITT population included all randomized participants who provided written informed consent.	days	MEDIAN
SECONDARY	Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4	Baseline until disease progression or death, approximately 2 years 6 months	The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.	days	MEDIAN
SECONDARY	Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	The ITT population included all randomized participants who provided written informed consent.	days	MEDIAN
PRIMARY	PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	Baseline until disease progression or death, approximately 2 years 6 months	The ITT population included all randomized participants who provided written informed consent.	days	MEDIAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group76

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

Outcome	Group	Value	Spread	Units
Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4	FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV	259	95% Confidence Interval 245 to 268	days
Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4	XELOX/XELOX+P/XELOX+BV	241	95% Confidence Interval 229 to 254	days
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4	FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV	304.0	95% Confidence Interval 281 to 319	days
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4	XELOX/XELOX+P/XELOX+BV	261.0	95% Confidence Interval 246 to 276	days
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	FOLFOX-4+P/XELOX+P	259.0	95% Confidence Interval 244 to 278	days
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	FOLFOX-4+BV/XELOX+BV	335.0	95% Confidence Interval 310 to 363	days
PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4	FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV	268.0	95% Confidence Interval 252 to 290	days
PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4	XELOX/XELOX+P/XELOX+BV	234.0	95% Confidence Interval 221 to 251	days
PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	FOLFOX-4+P/XELOX+P	241.0	95% Confidence Interval 227 to 254	days
PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone	FOLFOX-4+BV/XELOX+BV	316.0	95% Confidence Interval 294 to 338	days

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow54

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

Period	Milestone	Group	Participants
Primary Treatment Phase	STARTED	Xelox	317
Primary Treatment Phase	STARTED	Folfox-4	317
Primary Treatment Phase	STARTED	Xelox+P	350
Primary Treatment Phase	STARTED	Folfox-4+P	351
Primary Treatment Phase	STARTED	Xelox+BV	350
Primary Treatment Phase	STARTED	Folfox-4+BV	349
Primary Treatment Phase	COMPLETED	Xelox	22
Primary Treatment Phase	COMPLETED	Folfox-4	15
Primary Treatment Phase	COMPLETED	Xelox+P	36
Primary Treatment Phase	COMPLETED	Folfox-4+P	31

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events2,280

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	Diarrhoea	Gastrointestinal disorders	Xelox	207	316
other	Diarrhoea	Gastrointestinal disorders	Folfox-4	186	313
other	Diarrhoea	Gastrointestinal disorders	Xelox+P	208	339
other	Diarrhoea	Gastrointestinal disorders	Folfox-4+P	197	336
other	Diarrhoea	Gastrointestinal disorders	Xelox+BV	210	353
other	Diarrhoea	Gastrointestinal disorders	Folfox-4+BV	218	341
other	Nausea	Gastrointestinal disorders	Xelox	194	316
other	Nausea	Gastrointestinal disorders	Folfox-4	208	313
other	Nausea	Gastrointestinal disorders	Xelox+P	209	339
other	Nausea	Gastrointestinal disorders	Folfox-4+P	204	336

1 to 10 of 2,280Source ClinicalTrials.gov

See all 2,280 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Xelox
Total, all-cause mortality	Folfox-4
Total, all-cause mortality	Xelox+P
Total, all-cause mortality	Folfox-4+P
Total, all-cause mortality	Xelox+BV
Total, all-cause mortality	Folfox-4+BV
Total, other adverse events	Xelox	310	316
Total, other adverse events	Folfox-4	310	313
Total, other adverse events	Xelox+P	330	339
Total, other adverse events	Folfox-4+P	331	336

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

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.

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Read this trial from software.

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