Trial · NCT00561470
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
NCT00561470, Phase 3, Completed, Sanofi; results first posted 2012-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen. Trials, record NCT00561470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00561470
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
- NCT number
- NCT00561470
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,226 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis
- Interventions
- Placebo, Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- First posted
- 2007-11-21
- Last updated
- 2012-09-28
- Other registries' IDs
- eudract:2007-000820-42
- Results first posted
- 2012-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) | Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011). OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. |
| Secondary | Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) | From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months) | PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC. PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model. The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred. |
| Secondary | Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria | From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months) | The overall ORR was the percentage of evaluable participants who achieved complete response \[CR\] or partial response \[PR\] according to RECIST criteria version 1.0. * CR reflected the disappearance of all tumor lesions (with no new tumors) * PR reflected a pre-defined reduction in tumor burden Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks. |
| Secondary | Number of Participants With Adverse Events (AE) | From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized | All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported. |
| Secondary | Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay | Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo | Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) | Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) | From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months) | Intent to Treat (ITT) population included all participants who gave informed consent and were randomized. | months | MEDIAN |
| SECONDARY | Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria | From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months) | The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AE) | From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized | The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm). | participants | NUMBER |
| SECONDARY | Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay | Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo | Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Placebo/FOLFIRI | 12.06 | Inter-Quartile Range 6.83 to 21.03 | months | |
| Overall Survival (OS) | Aflibercept/FOLFIRI | 13.50 | Inter-Quartile Range 7.62 to 25.59 | months | |
| Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) | Placebo/FOLFIRI | 4.67 | Inter-Quartile Range 2.60 to 9.10 | months | |
| Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) | Aflibercept/FOLFIRI | 6.90 | Inter-Quartile Range 3.84 to 10.05 | months | |
| Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria | Placebo/FOLFIRI | 11.1 | 95% Confidence Interval 8.5 to 13.8 | percentage of participants | |
| Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria | Aflibercept/FOLFIRI | 19.8 | 95% Confidence Interval 16.4 to 23.2 | percentage of participants | |
| Number of Participants With Adverse Events (AE) | Placebo/FOLFIRI | Treatment-Emergent Adverse Event (TEAE) | 592 | participants | |
| Number of Participants With Adverse Events (AE) | Aflibercept/FOLFIRI | Treatment-Emergent Adverse Event (TEAE) | 606 | participants | |
| Number of Participants With Adverse Events (AE) | Placebo/FOLFIRI | Serious TEAE | 198 | participants | |
| Number of Participants With Adverse Events (AE) | Aflibercept/FOLFIRI | Serious TEAE | 294 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/FOLFIRI | 614 | |
| Overall Study | STARTED | Aflibercept/FOLFIRI | 612 | |
| Overall Study | TREATED | Placebo/FOLFIRI | 609 | |
| Overall Study | TREATED | Aflibercept/FOLFIRI | 607 | |
| Overall Study | SAFETY POPULATION | Placebo/FOLFIRI | 605 | |
| Overall Study | SAFETY POPULATION | Aflibercept/FOLFIRI | 611 | |
| Overall Study | ONGOING TREATMENT | Placebo/FOLFIRI | 11 | |
| Overall Study | ONGOING TREATMENT | Aflibercept/FOLFIRI | 14 | |
| Overall Study | COMPLETED | Placebo/FOLFIRI | 0 | |
| Overall Study | COMPLETED | Aflibercept/FOLFIRI | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events586
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 | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Placebo/FOLFIRI | 35 | 605 | |
| other | Urinary tract infection | Infections and infestations | Aflibercept/FOLFIRI | 51 | 611 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo/FOLFIRI | 202 | 605 | |
| other | Neutropenia | Blood and lymphatic system disorders | Aflibercept/FOLFIRI | 229 | 611 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo/FOLFIRI | 143 | 605 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Aflibercept/FOLFIRI | 195 | 611 | |
| other | Dehydration | Metabolism and nutrition disorders | Placebo/FOLFIRI | 12 | 605 | |
| other | Dehydration | Metabolism and nutrition disorders | Aflibercept/FOLFIRI | 33 | 611 | |
| other | Insomnia | Psychiatric disorders | Placebo/FOLFIRI | 45 | 605 | |
| other | Insomnia | Psychiatric disorders | Aflibercept/FOLFIRI | 47 | 611 |
1 to 10 of 586Source ClinicalTrials.gov
See all 586 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/FOLFIRI | ||
| Total, all-cause mortality | Aflibercept/FOLFIRI | ||
| Total, other adverse events | Placebo/FOLFIRI | 575 | 605 |
| Total, other adverse events | Aflibercept/FOLFIRI | 599 | 611 |
| Total, serious adverse events | Placebo/FOLFIRI | 198 | 605 |
| Total, serious adverse events | Aflibercept/FOLFIRI | 294 | 611 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Aflibercept/FOLFIRI vs Placebo/FOLFIRI: serious adverse events |
Source Trial comparisons
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.
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/NCT00561470
GET https://conductscience.org/api/trials/v1/NCT00561470/events?page=2