18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free SurvivalPrimary· 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.
Group
Value
95% CI
Wild-type KRAS - FOLFOX + Panitumumab
9.6
9.2 – 11.1
Wild-type KRAS - FOLFOX
8.0
7.5 – 9.3
Mutant KRAS - FOLFOX + Panitumumab
7.3
6.3 – 8.0
Mutant KRAS - FOLFOX
8.8
7.7 – 9.4
Overall SurvivalSecondary· 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.
Group
Value
95% CI
Wild-type KRAS - FOLFOX + Panitumumab
23.9
20.3 – 28.3
Wild-type KRAS - FOLFOX
19.7
17.6 – 22.6
Mutant KRAS - FOLFOX + Panitumumab
15.5
13.1 – 17.6
Mutant KRAS - FOLFOX
19.3
16.5 – 21.8
Percentage of Participants With an Objective ResponseSecondary· 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 t
Group
Value
95% CI
Wild-type KRAS - FOLFOX + Panitumumab
55.21
49.55 – 60.77
Wild-type KRAS - FOLFOX
47.68
42.12 – 53.28
Mutant KRAS - FOLFOX + Panitumumab
39.53
32.95 – 46.41
Mutant KRAS - FOLFOX
40.28
33.61 – 47.24
Time to ProgressionSecondary· 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.
Group
Value
95% CI
Wild-type KRAS - FOLFOX + Panitumumab
10.8
9.4 – 12.4
Wild-type KRAS - FOLFOX
9.2
7.7 – 9.9
Mutant KRAS - FOLFOX + Panitumumab
7.5
7.2 – 8.9
Mutant KRAS - FOLFOX
9.0
7.7 – 9.5
Duration of ResponseSecondary· 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.
Group
Value
95% CI
Wild-type KRAS - FOLFOX + Panitumumab
11.1
9.5 – 13.0
Wild-type KRAS - FOLFOX
8.8
7.8 – 9.7
Mutant KRAS - FOLFOX + Panitumumab
7.4
5.9 – 8.3
Mutant KRAS - FOLFOX
8.0
6.5 – 9.5
Number of Participants With Adverse Events (AEs)Secondary· 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?"
Any adverse event
Group
Value
95% CI
FOLFOX + Panitumumab
583
FOLFOX Alone
579
Serious adverse event
Group
Value
95% CI
FOLFOX + Panitumumab
262
FOLFOX Alone
198
Leading to discontinuation of any study drug
Group
Value
95% CI
FOLFOX + Panitumumab
136
FOLFOX Alone
84
Treatment-related adverse event (TRAE)
Group
Value
95% CI
FOLFOX + Panitumumab
581
FOLFOX Alone
565
Serious treatment-related adverse event
Group
Value
95% CI
FOLFOX + Panitumumab
162
FOLFOX Alone
89
TRAE leading to discontinuation of any study drug
Group
Value
95% CI
FOLFOX + Panitumumab
117
FOLFOX Alone
63
Adverse events — posted to ClinicalTrials.gov
Time frame: The median treatment period was around 7.7 months in the Panitumumab arm, and around 6.7 months in the Chemo alone arm..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Panitumumab Plus FOLFOX
Serious: 262/585 (45%)
Deaths: —
FOLFOX Alone
Serious: 198/584 (34%)
Deaths: —
Serious adverse events (295 terms)
Reaction
System
Panitumumab Plus FOLFOX
FOLFOX Alone
Diarrhoea
Gastrointestinal disorders
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Rash
Skin and subcutaneous tissue disorders
—
—
Anorexia
Metabolism and nutrition disorders
—
—
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 7 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00364013.