Trial · NCT00364013
PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
NCT00364013, Phase 3, Completed, Amgen; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy. Trials, record NCT00364013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00364013
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
- NCT number
- NCT00364013
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,183 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Panitumumab, FOLFOX regimen
- First posted
- 2006-08-15
- Last updated
- 2022-11-07
- Results first posted
- 2014-03-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks. | Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date. Progressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions. |
| Secondary | Overall Survival | From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks. | The definition of overall survival is the time from randomization to death; participants who were alive at the analysis data cutoff were censored at their last contact date. |
| Secondary | Percentage of Participants With an Objective Response | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response by central radiological assessment was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on the first-line treatment, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. |
| Secondary | Time to Progression | From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | Time to progression was defined as time from randomization date to date of disease progression per the modified RECIST criteria. |
| Secondary | Duration of Response | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | Duration of response was calculated only for those participants with a confirmed CR or PR, as the time from the first CR or PR (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified RECIST criteria, based on a blinded central review. |
| Secondary | Number of Participants With Adverse Events (AEs) | From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks. | A serious adverse event (SAE) is defined as an AE that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?" |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks. | KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed) | months | MEDIAN |
| SECONDARY | Overall Survival | From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 153 weeks. | KRAS Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | KRAS Evaluable Central Tumor Response Analysis Set (subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review). | percentage of participants | NUMBER |
| SECONDARY | Time to Progression | From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | KRAS Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | Duration of Response | Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks. | KRAS Evaluable Central Tumor Response Analysis Set: Responders | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 153 weeks. | Safety analysis set; One participant was randomized to 'Panitumumab Plus FOLFOX', but received 'FOLFOX Alone' so is counted in that group. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Wild-type KRAS - FOLFOX + Panitumumab | 9.6 | 95% Confidence Interval 9.2 to 11.1 | months | |
| Progression-free Survival | Wild-type KRAS - FOLFOX | 8.0 | 95% Confidence Interval 7.5 to 9.3 | months | |
| Progression-free Survival | Mutant KRAS - FOLFOX + Panitumumab | 7.3 | 95% Confidence Interval 6.3 to 8.0 | months | |
| Progression-free Survival | Mutant KRAS - FOLFOX | 8.8 | 95% Confidence Interval 7.7 to 9.4 | months | |
| Overall Survival | Wild-type KRAS - FOLFOX + Panitumumab | 23.9 | 95% Confidence Interval 20.3 to 28.3 | months | |
| Overall Survival | Wild-type KRAS - FOLFOX | 19.7 | 95% Confidence Interval 17.6 to 22.6 | months | |
| Overall Survival | Mutant KRAS - FOLFOX + Panitumumab | 15.5 | 95% Confidence Interval 13.1 to 17.6 | months | |
| Overall Survival | Mutant KRAS - FOLFOX | 19.3 | 95% Confidence Interval 16.5 to 21.8 | months | |
| Percentage of Participants With an Objective Response | Wild-type KRAS - FOLFOX + Panitumumab | 55.21 | 95% Confidence Interval 49.55 to 60.77 | percentage of participants | |
| Percentage of Participants With an Objective Response | Wild-type KRAS - FOLFOX | 47.68 | 95% Confidence Interval 42.12 to 53.28 | percentage of participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FOLFOX + Panitumumab | 593 | |
| Overall Study | STARTED | FOLFOX Alone | 590 | |
| Overall Study | Received Study Drug | FOLFOX + Panitumumab | 586 | |
| Overall Study | Received Study Drug | FOLFOX Alone | 583 | |
| Overall Study | COMPLETED | FOLFOX + Panitumumab | 492 | |
| Overall Study | COMPLETED | FOLFOX Alone | 495 | |
| Overall Study | NOT COMPLETED | FOLFOX + Panitumumab | 101 | |
| Overall Study | NOT COMPLETED | FOLFOX Alone | 95 |
Source ClinicalTrials.gov
Adverse events702
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 | Panitumumab Plus FOLFOX | 84 | 585 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFOX Alone | 81 | 584 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFOX | 48 | 585 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFOX Alone | 50 | 584 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFOX | 315 | 585 | |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFOX Alone | 353 | 584 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFOX | 115 | 585 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFOX Alone | 157 | 584 | |
| other | Conjunctivitis | Eye disorders | Panitumumab Plus FOLFOX | 103 | 585 | |
| other | Conjunctivitis | Eye disorders | FOLFOX Alone | 20 | 584 |
1 to 10 of 702Source ClinicalTrials.gov
See all 702 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab Plus FOLFOX | ||
| Total, all-cause mortality | FOLFOX Alone | ||
| Total, other adverse events | Panitumumab Plus FOLFOX | 577 | 585 |
| Total, other adverse events | FOLFOX Alone | 571 | 584 |
| Total, serious adverse events | Panitumumab Plus FOLFOX | 262 | 585 |
| Total, serious adverse events | FOLFOX Alone | 198 | 584 |
Source ClinicalTrials.gov
Papers15
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 |
|---|
| Panitumumab Plus FOLFOX vs FOLFOX Alone: 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/NCT00364013
GET https://conductscience.org/api/trials/v1/NCT00364013/results?page=2