Metastatic Colorectal CancerPhase 3NCT00339183

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

A Phase 3 study testing Panitumumab and FOLFIRI in people with Metastatic Colorectal Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Colorectal Cancer
What is being tested?: Panitumumab and FOLFIRI
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,186 participants
Where: No sites listed yet
Study dates: 30 Jun 2006to 1 Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Man or woman at least 18 years old
Diagnosis of metastatic colorectal cancer (mCRC)
One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2

Show all 10Show fewer

Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
Adequate hematologic, renal, and hepatic functions
Negative pregnancy test within 72 hours of enrollment
Other protocol-specified criteria may apply

Who cannot join

History of or known presence of central nervous system (CNS) metastases
History of another primary cancer within 5 years of randomization
Prior irinotecan therapy
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
Any investigational agent or therapy within 30 days before randomization
Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin

Show all 13Show fewer

History of interstitial lung disease or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
Known positive tests for human immunodefiency virus (HIV), hepatitis C viris (HCV), acute or chronic active hepatitis B virus (HBV)
Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
Pregnant or breast-feeding
Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
Other protocol-specified criteria may apply

About this study

Official title: A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer

The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

Conditions: Metastatic Colorectal Cancer
Being tested: Panitumumab, FOLFIRI
Keywords: Oncology, Cancer, Metastatic Colorectal Cancer, EGFr, Panitumumab, Clinical Trial, Amgen
Medical subject headings: Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PanitumumabDrug
Also called Vectibix®
Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.
FOLFIRIDrug
FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 racemate (or 200 mg/m^2 I-leucovorin), 5-FU bolus 400 mg/m^2, 5-FU infusion 2400 mg/m^2.

Study groups in NCT00339183
Study group	Role	What they receive
Panitumumab Plus FOLFIRI	Experimental	Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks. Receives: Drug: Panitumumab; Drug: FOLFIRI
FOLFIRI Alone	Active comparator	Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks. Receives: Drug: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS)
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.
Measured: From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.
Overall Survival
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.
Measured: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months

Secondary outcomes (4)

Percentage of Participants With an Objective Response
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.
Measured: 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.
Time to Disease Progression
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.
Measured: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Duration of Response
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.
Measured: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Number of Participants With Adverse Events (AEs)
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?"
Measured: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20061 Nov 2010

First posted20 Jun 2006 (estimated)
Study start30 Jun 2006
Primary completion1 Apr 2009
Study completion1 Nov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00339183
Sponsor's protocol ID: 20050181
Status last verified: Sep 2022
First submitted: 16 Jun 2006
Last updated: 23 Sep 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tian Y, Sidhu R. Final results from a randomized phase 3 study of FOLFIRI +/- panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jan;25(1):107-16. doi: 10.1093/annonc/mdt523.
PubMed 24356622
Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.
PubMed 20921462
Author and team decided to wait for CALGB RAS data presented Sept 29 at ESMO.
Peeters M, Price T, Taieb J, Geissler M, Rivera F, Canon JL, Pentheroudakis G, Koukakis R, Burdon P, Siena S. Relationships between tumour response and primary tumour location, and predictors of long-term survival, in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab therapy: retrospective analyses of the PRIME and PEAK clinical trials. Br J Cancer. 2018 Aug;119(3):303-312. doi: 10.1038/s41416-018-0165-z. Epub 2018 Jul 17.
PubMed 30013091
Shi Y, Wan X, Tan C, Li J, Peng L. Model-Based Cost-Effectiveness Analysis of Panitumumab Plus FOLFIRI for the Second-Line Treatment of Patients with Wild-Type Ras Metastatic Colorectal Cancer. Adv Ther. 2020 Feb;37(2):847-859. doi: 10.1007/s12325-019-01214-y. Epub 2020 Jan 4.
PubMed 31902066
Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8.
PubMed 29627309
Peeters M, Oliner KS, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, He P, Yu H, Koukakis R, Terwey JH, Jung AS, Sidhu R, Patterson SD. Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer. Clin Cancer Res. 2015 Dec 15;21(24):5469-79. doi: 10.1158/1078-0432.CCR-15-0526. Epub 2015 Sep 4.
PubMed 26341920
Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
PubMed 26049686
Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
PubMed 22070868

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC

All Metastatic Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Chemotherapy to the Efficacy of Chemotherapy Alone in Patients With Previously Treated Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00339183
Acronym / sponsor ID: 20050181
Conditions: Metastatic Colorectal Cancer
Keywords: Oncology, Cancer, Metastatic Colorectal Cancer, EGFr, Panitumumab, Clinical Trial, Amgen
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,186 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 30 Jun 2006 (actual)
Primary completion: 1 Apr 2009 (actual)
Study completion: 1 Nov 2010 (actual)
First posted: 20 Jun 2006 (estimated)
Results: Posted 6 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Panitumumab Plus FOLFIRI	Experimental	Drug: Panitumumab, Drug: FOLFIRIParticipants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
FOLFIRI Alone	Active comparator	Drug: FOLFIRIParticipants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Man or woman at least 18 years old
Diagnosis of metastatic colorectal cancer (mCRC)
One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
Radiologically documented disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria during treatment or within 6 months of last dose of first-line chemotherapy
At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST

Key exclusion criteria (13 listed)

History of or known presence of central nervous system (CNS) metastases
History of another primary cancer within 5 years of randomization
Prior irinotecan therapy
Prior anti-epidermal growth factor receptor (EGFr) antibody therapy or treatment with small molecule EGFr inhibitors
Any investigational agent or therapy within 30 days before randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PanitumumabAlso: Vectibix®Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.	Drug	Panitumumab Plus FOLFIRI
FOLFIRIFOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m^2, leucovorin 400 mg/m^2 racemate (or 200 mg/m^2 I-leucovorin), 5-FU bolus 400 mg/m^2, 5-FU infusion 2400 mg/m^2.	Drug	FOLFIRI Alone, Panitumumab Plus FOLFIRI

Primary outcome

Progression-free Survival (PFS)
Time frame: 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.
Overall Survival
Time frame: 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.

4 secondary outcomes

Percentage of Participants With an Objective Response
Time frame: 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.
Time to Disease Progression
Time frame: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Duration of Response
Time frame: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months
Number of Participants With Adverse Events (AEs)
Time frame: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.

Results and safety

Results posted to the registry on 6 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panitumumab Plus FOLFIRI	591	470
FOLFIRI Alone	595	490

Primary outcome: Progression-free Survival (PFS)

Time frame: From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.. Median (95% Confidence Interval). Unit: months

Measure	Wild-type KRAS - Panitumumab Plus FOLFIRI n = 303	Wild-type KRAS - FOLFIRI Alone n = 294	Mutant KRAS - Panitumumab Plus FOLFIRI n = 238	Mutant KRAS - FOLFIRI Alone n = 248
Value	5.9 (5.5 to 6.7)	3.9 (3.7 to 5.3)	5.0 (3.8 to 5.6)	4.9 (3.6 to 5.6)

Wild-type KRAS - Panitumumab Plus FOLFIRI vs Wild-type KRAS - FOLFIRI Alone: Normal score: -2.91, p = 0.0036, Stratified log-rank test
Mutant KRAS - Panitumumab Plus FOLFIRI vs Mutant KRAS - FOLFIRI Alone: Normal score: -1.46, p = 0.1448, Stratified log-rank test

Population analysed: KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)

Primary outcome: Overall Survival

Time frame: From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months. Median (95% Confidence Interval). Unit: months

Measure	Wild-type KRAS - Panitumumab Plus FOLFIRI n = 303	Wild-type KRAS - FOLFIRI Alone n = 294	Mutant KRAS - Panitumumab Plus FOLFIRI n = 238	Mutant KRAS - FOLFIRI Alone n = 248
Value	14.5 (13.0 to 16.0)	12.5 (11.2 to 14.2)	11.8 (10.4 to 13.3)	11.1 (10.3 to 12.4)

Wild-type KRAS - Panitumumab Plus FOLFIRI vs Wild-type KRAS - FOLFIRI Alone: Normal score: -1.57, p = 0.1154, Stratified log-rank test
Mutant KRAS - Panitumumab Plus FOLFIRI vs Mutant KRAS - FOLFIRI Alone: Normal score: -0.60, p = 0.5503, Stratified log-rank test

Population analysed: KRAS Efficacy Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The median treatment period was approximately 6.2 months in the Panitumumab plus FOLFIRI arm, and 4.7 months in the FOLFIRI Alone arm.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panitumumab Plus FOLFIRI	232 of 587 (39.5%)	575 of 587 (98%)	Not reported
FOLFIRI Alone	175 of 594 (29.5%)	546 of 594 (91.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24356622Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tian Y, Sidhu R. Final results from a randomized phase 3 study of FOLFIRI +/- panitumumab for second-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jan;25(1):107-16. doi: 10.1093/annonc/mdt523.
Background: PubMed 20921462Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.
BackgroundAuthor and team decided to wait for CALGB RAS data presented Sept 29 at ESMO.
Background: PubMed 30013091Peeters M, Price T, Taieb J, Geissler M, Rivera F, Canon JL, Pentheroudakis G, Koukakis R, Burdon P, Siena S. Relationships between tumour response and primary tumour location, and predictors of long-term survival, in patients with RAS wild-type metastatic colorectal cancer receiving first-line panitumumab therapy: retrospective analyses of the PRIME and PEAK clinical trials. Br J Cancer. 2018 Aug;119(3):303-312. doi: 10.1038/s41416-018-0165-z. Epub 2018 Jul 17.
Derived from this study: PubMed 31902066Shi Y, Wan X, Tan C, Li J, Peng L. Model-Based Cost-Effectiveness Analysis of Panitumumab Plus FOLFIRI for the Second-Line Treatment of Patients with Wild-Type Ras Metastatic Colorectal Cancer. Adv Ther. 2020 Feb;37(2):847-859. doi: 10.1007/s12325-019-01214-y. Epub 2020 Jan 4.
Derived from this study: PubMed 29627309Boeckx N, Koukakis R, Op de Beeck K, Rolfo C, Van Camp G, Siena S, Tabernero J, Douillard JY, Andre T, Peeters M. Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies. Clin Colorectal Cancer. 2018 Sep;17(3):170-178.e3. doi: 10.1016/j.clcc.2018.03.005. Epub 2018 Mar 8.
Derived from this study: PubMed 26341920Peeters M, Oliner KS, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, He P, Yu H, Koukakis R, Terwey JH, Jung AS, Sidhu R, Patterson SD. Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer. Clin Cancer Res. 2015 Dec 15;21(24):5469-79. doi: 10.1158/1078-0432.CCR-15-0526. Epub 2015 Sep 4.
Derived from this study: PubMed 26049686Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
Derived from this study: PubMed 22070868Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Panitumumab and FOLFIRI in people with Metastatic Colorectal Cancer, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00339183, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.