NCT00339183

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,186

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

June 30, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

May 6, 2014

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.8 years

First QC Date

June 16, 2006

Results QC Date

April 3, 2014

Last Update Submit

September 12, 2022

Conditions

Metastatic Colorectal Cancer

Keywords

OncologyCancerMetastatic Colorectal CancerEGFrPanitumumabClinical TrialAmgen

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months

  • Duration of Response

    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)

    From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.

Study Arms (2)

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.

Drug: PanitumumabDrug: 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.

Drug: FOLFIRI

Interventions

PanitumumabDRUG

Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.

Also known as: Vectibix®
Panitumumab Plus FOLFIRI
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.

FOLFIRI AlonePanitumumab Plus FOLFIRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 24356622BACKGROUND

  • 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.

    PMID: 20921462BACKGROUND

  • Author and team decided to wait for CALGB RAS data presented Sept 29 at ESMO.

    BACKGROUND

  • 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.

    PMID: 30013091BACKGROUND

  • 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.

    PMID: 31902066DERIVED

  • 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.

    PMID: 29627309DERIVED

  • 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.

    PMID: 26341920DERIVED

  • 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.

    PMID: 26049686DERIVED

  • 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.

    PMID: 22070868DERIVED

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Interventions

PanitumumabIFL protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 30, 2006

Primary Completion

April 1, 2009

Study Completion

November 1, 2010

Last Updated

September 23, 2022

Results First Posted

May 6, 2014

Record last verified: 2022-09