Trial · NCT00115765
PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
NCT00115765, Phase 3, Completed, Amgen; results first posted 2010-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study. Trials, record NCT00115765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00115765
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
- NCT number
- NCT00115765
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Colorectal Cancer
- Interventions
- Oxaliplatin Based Chemotherapy, Panitumumab, Irinotecan Based Chemotherapy, Bevacizumab
- First posted
- 2005-06-27
- Last updated
- 2018-10-17
- Results first posted
- 2010-09-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (Oxaliplatin) | Overall study | Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression |
| Primary | Objective Tumor Response Through Week 12 (Irinotecan) | Overall Study | Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum |
| Secondary | Overall Survival (Oxaliplatin) | Overall study | Kaplan-Meier estimate of the median time from randomization to death from any cause in groups treated with Oxaliplatin |
| Secondary | Objective Tumor Response Rate (Oxaliplatin) | Overall study | Best overall response of complete or partial response within oxaliplatin stratum |
| Secondary | Time to Progression (Oxaliplatin) | Overall Study | Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the oxaliplatin stratum |
| Secondary | Time to Treatment Failure (Oxaliplatin) | Overall study | Kaplan-Meier estimate of the median time from randomization to the date the decision was made to discontinue treatment for a reason other than a complete response to treatment within the oxaliplatin stratum. |
| Secondary | Overall Survival (Irinotecan) | Overall study | Incidence of mortality from any cause in groups treated with Irinotecan. Incidence is provided in lieu of the median time to death since the median or its measure of dispersion was not estimable for at least one treatment arm. |
| Secondary | Progression-free Survival (Irinotecan) | Overall Study | Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression |
| Secondary | Objective Tumor Response Rate (Irinotecan) | Overall Study | Best overall response of complete or partial response within irinotecan stratum |
| Secondary | Time to Progression (Irinotecan) | Overall Study | Kaplan-Meier estimate of the median time from randomization to disease progression or death due to disease progression within the irinotecan stratum |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (Oxaliplatin) | Overall study | Intention-to-Treat | Month | MEDIAN |
| SECONDARY | Overall Survival (Oxaliplatin) | Overall study | Intention-to-Treat | Month | MEDIAN |
| SECONDARY | Objective Tumor Response Rate (Oxaliplatin) | Overall study | Intention-to-Treat | Participant | NUMBER |
| SECONDARY | Time to Progression (Oxaliplatin) | Overall Study | Intention-to-Treat | Month | MEDIAN |
| SECONDARY | Time to Treatment Failure (Oxaliplatin) | Overall study | Intention-to-Treat | Month | MEDIAN |
| PRIMARY | Objective Tumor Response Through Week 12 (Irinotecan) | Overall Study | Intention-to-Treat | Participant | NUMBER |
| SECONDARY | Overall Survival (Irinotecan) | Overall study | Intention-to-Treat | Participant | NUMBER |
| SECONDARY | Progression-free Survival (Irinotecan) | Overall Study | Intention-to-Treat | Month | MEDIAN |
| POST_HOC | Progression-free Survival (Wild-type KRAS) | Overall Study | Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as wild-type, who were treated with oxaliplatin | Month | MEDIAN |
| POST_HOC | Progression-free Survival (Mutant KRAS) | Overall Study | Subset of the KRAS Efficacy Analysis Set, composed of participants from the intention-to-treat set who received at least 1 dose of first-line treatment and for whom KRAS mutation status was assessed as mutant, who were treated with oxaliplatin | Month | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (Oxaliplatin) | Oxaliplatin and Bevacizumab Plus Panitumumab | 10.0 | 95% Confidence Interval 8.9 to 11.0 | Month | |
| Progression-Free Survival (Oxaliplatin) | Oxaliplatin and Bevacizumab Without Panitumumab | 11.4 | 95% Confidence Interval 10.5 to 11.9 | Month | |
| Overall Survival (Oxaliplatin) | Oxaliplatin and Bevacizumab Plus Panitumumab | 19.4 | 95% Confidence Interval 18.4 to 20.8 | Month | |
| Overall Survival (Oxaliplatin) | Oxaliplatin and Bevacizumab Without Panitumumab | 24.5 | 95% Confidence Interval 20.4 to 24.5 | Month | |
| Objective Tumor Response Rate (Oxaliplatin) | Oxaliplatin and Bevacizumab Plus Panitumumab | 190 | Participant | ||
| Objective Tumor Response Rate (Oxaliplatin) | Oxaliplatin and Bevacizumab Without Panitumumab | 196 | Participant | ||
| Time to Progression (Oxaliplatin) | Oxaliplatin and Bevacizumab Plus Panitumumab | 10.8 | 95% Confidence Interval 9.5 to 11.3 | Month | |
| Time to Progression (Oxaliplatin) | Oxaliplatin and Bevacizumab Without Panitumumab | 11.4 | 95% Confidence Interval 10.9 to 12.2 | Month | |
| Time to Treatment Failure (Oxaliplatin) | Oxaliplatin and Bevacizumab Plus Panitumumab | 5.7 | 95% Confidence Interval 5.5 to 6.0 | Month | |
| Time to Treatment Failure (Oxaliplatin) | Oxaliplatin and Bevacizumab Without Panitumumab | 5.9 | 95% Confidence Interval 5.7 to 6.2 | Month |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irinotecan and Bevacizumab Without Panitumumab | 115 | |
| Overall Study | STARTED | Oxaliplatin and Bevacizumab Plus Panitumumab | 413 | |
| Overall Study | STARTED | Oxaliplatin and Bevacizumab Without Panitumumab | 410 | |
| Overall Study | STARTED | Irinotecan and Bevacizumab Plus Panitumumab | 115 | |
| Overall Study | COMPLETED | Irinotecan and Bevacizumab Without Panitumumab | 80 | |
| Overall Study | COMPLETED | Oxaliplatin and Bevacizumab Plus Panitumumab | 313 | |
| Overall Study | COMPLETED | Oxaliplatin and Bevacizumab Without Panitumumab | 289 | |
| Overall Study | COMPLETED | Irinotecan and Bevacizumab Plus Panitumumab | 84 | |
| Overall Study | NOT COMPLETED | Irinotecan and Bevacizumab Without Panitumumab | 35 | |
| Overall Study | NOT COMPLETED | Oxaliplatin and Bevacizumab Plus Panitumumab | 100 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events854
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 | ANAEMIA | Blood and lymphatic system disorders | Panit. Plus Bevacizumab With Chemotherapy | 177 | 518 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Bevacizumab With Chemotherapy | 147 | 510 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Panit. Plus Bevacizumab With Chemotherapy | 53 | 518 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Bevacizumab With Chemotherapy | 60 | 510 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Panit. Plus Bevacizumab With Chemotherapy | 179 | 518 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Bevacizumab With Chemotherapy | 207 | 510 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Panit. Plus Bevacizumab With Chemotherapy | 71 | 518 | |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Bevacizumab With Chemotherapy | 108 | 510 | |
| other | CONJUNCTIVITIS | Eye disorders | Panit. Plus Bevacizumab With Chemotherapy | 31 | 518 | |
| other | CONJUNCTIVITIS | Eye disorders | Bevacizumab With Chemotherapy | 6 | 510 |
1 to 10 of 854Source ClinicalTrials.gov
See all 854 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panit. Plus Bevacizumab With Chemotherapy | ||
| Total, all-cause mortality | Bevacizumab With Chemotherapy | ||
| Total, other adverse events | Panit. Plus Bevacizumab With Chemotherapy | 516 | 518 |
| Total, other adverse events | Bevacizumab With Chemotherapy | 505 | 510 |
| Total, serious adverse events | Panit. Plus Bevacizumab With Chemotherapy | 306 | 518 |
| Total, serious adverse events | Bevacizumab With Chemotherapy | 188 | 510 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| Panit. Plus Bevacizumab With Chemotherapy vs Bevacizumab With Chemotherapy: 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/NCT00115765
GET https://conductscience.org/api/trials/v1/NCT00115765/results?page=2