Trial · NCT00339183
Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
NCT00339183, Phase 3, Completed, Amgen; results first posted 2014-05-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone. Trials, record NCT00339183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00339183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
- NCT number
- NCT00339183
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,186 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Panitumumab, FOLFIRI
- First posted
- 2006-06-20
- Last updated
- 2022-09-23
- Results first posted
- 2014-05-06
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 (PFS) | From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months. | Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. 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. |
| Primary | Overall Survival | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | Overall survival was defined as the time from randomization to the date of death. Participants who had not died by the analysis data cutoff date had their time of death 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 April 2009. Maximum time on follow-up was 33 months. | 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 was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, 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 Disease Progression | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | Time to progression was defined as the time from the randomization date to the date of first observed disease progression per the modified RECIST criteria. Participants not meeting these criteria by the analysis 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 | Duration of Response | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | Calculated only for those participants with an objective response as the time from the first objective response (subsequently confirmed within no less than 4 weeks) to first observed disease progression per modified-RECIST criteria. Participants not meeting these criteria by the analysis 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 | Number of Participants With Adverse Events (AEs) | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months. | A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • 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 (PFS) | From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months. | KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed) | months | MEDIAN |
| PRIMARY | Overall Survival | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | 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 April 2009. Maximum time on follow-up was 33 months. | KRAS 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 for whom KRAS was assessed. | percentage of participants | NUMBER |
| SECONDARY | Time to Disease Progression | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | KRAS Efficacy Analysis Set | months | MEDIAN |
| SECONDARY | Duration of Response | From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months | KRAS 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 30 April 2009. Maximum follow-up time was 33 months. | Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses. | 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 (PFS) | Wild-type KRAS - Panitumumab Plus FOLFIRI | 5.9 | 95% Confidence Interval 5.5 to 6.7 | months | |
| Progression-free Survival (PFS) | Wild-type KRAS - FOLFIRI Alone | 3.9 | 95% Confidence Interval 3.7 to 5.3 | months | |
| Progression-free Survival (PFS) | Mutant KRAS - Panitumumab Plus FOLFIRI | 5.0 | 95% Confidence Interval 3.8 to 5.6 | months | |
| Progression-free Survival (PFS) | Mutant KRAS - FOLFIRI Alone | 4.9 | 95% Confidence Interval 3.6 to 5.6 | months | |
| Overall Survival | Wild-type KRAS - Panitumumab Plus FOLFIRI | 14.5 | 95% Confidence Interval 13.0 to 16.0 | months | |
| Overall Survival | Wild-type KRAS - FOLFIRI Alone | 12.5 | 95% Confidence Interval 11.2 to 14.2 | months | |
| Overall Survival | Mutant KRAS - Panitumumab Plus FOLFIRI | 11.8 | 95% Confidence Interval 10.4 to 13.3 | months | |
| Overall Survival | Mutant KRAS - FOLFIRI Alone | 11.1 | 95% Confidence Interval 10.3 to 12.4 | months | |
| Percentage of Participants With an Objective Response | Wild-type KRAS - Panitumumab Plus FOLFIRI | 35.35 | 95% Confidence Interval 29.92 to 41.08 | percentage of participants | |
| Percentage of Participants With an Objective Response | Wild-type KRAS - FOLFIRI Alone | 9.82 | 95% Confidence Interval 6.63 to 13.89 | 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 | Panitumumab Plus FOLFIRI | 591 | |
| Overall Study | STARTED | FOLFIRI Alone | 595 | |
| Overall Study | Received Study Drug | Panitumumab Plus FOLFIRI | 588 | |
| Overall Study | Received Study Drug | FOLFIRI Alone | 593 | |
| Overall Study | COMPLETED | Panitumumab Plus FOLFIRI | 470 | |
| Overall Study | COMPLETED | FOLFIRI Alone | 490 | |
| Overall Study | NOT COMPLETED | Panitumumab Plus FOLFIRI | 121 | |
| Overall Study | NOT COMPLETED | FOLFIRI Alone | 105 |
Source ClinicalTrials.gov
Adverse events660
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 FOLFIRI | 79 | 587 | |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI Alone | 110 | 594 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 64 | 587 | |
| other | Leukopenia | Blood and lymphatic system disorders | FOLFIRI Alone | 60 | 594 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 207 | 587 | |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI Alone | 209 | 594 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panitumumab Plus FOLFIRI | 20 | 587 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFIRI Alone | 39 | 594 | |
| other | Conjunctivitis | Eye disorders | Panitumumab Plus FOLFIRI | 81 | 587 | |
| other | Conjunctivitis | Eye disorders | FOLFIRI Alone | 11 | 594 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab Plus FOLFIRI | ||
| Total, all-cause mortality | FOLFIRI Alone | ||
| Total, other adverse events | Panitumumab Plus FOLFIRI | 575 | 587 |
| Total, other adverse events | FOLFIRI Alone | 546 | 594 |
| Total, serious adverse events | Panitumumab Plus FOLFIRI | 232 | 587 |
| Total, serious adverse events | FOLFIRI Alone | 175 | 594 |
Source ClinicalTrials.gov
Papers8
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 FOLFIRI vs FOLFIRI 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/NCT00339183
GET https://conductscience.org/api/trials/v1/NCT00339183/results?page=2