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Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00339183
Recruitment Status : Completed
First Posted : June 20, 2006
Results First Posted : May 6, 2014
Last Update Posted : September 23, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE June 16, 2006
First Posted Date  ICMJE June 20, 2006
Results First Submitted Date  ICMJE April 3, 2014
Results First Posted Date  ICMJE May 6, 2014
Last Update Posted Date September 23, 2022
Actual Study Start Date  ICMJE June 30, 2006
Actual Primary Completion Date April 1, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
Efficacy: Overall Survival (OS) and progression-free survival (PFS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • 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. ]
    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.
  • 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 ]
    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.
  • Duration of Response [ Time Frame: 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.
  • 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. ]
    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?"
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2006)
Efficacy: Overall objective response rate, time to progression, and duration of response. Safety: Incidence of AEs and significant laboratory changes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Drug: Panitumumab
    Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy.
    Other Name: Vectibix®
  • Drug: FOLFIRI
    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 Arms  ICMJE
  • Experimental: Panitumumab Plus FOLFIRI
    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.
    Interventions:
    • Drug: Panitumumab
    • Drug: FOLFIRI
  • Active Comparator: FOLFIRI Alone
    Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
    Intervention: Drug: FOLFIRI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2010)
1186
Original Enrollment  ICMJE
 (submitted: June 16, 2006)
1100
Actual Study Completion Date  ICMJE November 1, 2010
Actual Primary Completion Date April 1, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Belgium,   Bulgaria,   Czech Republic,   Finland,   France,   Germany,   Ireland,   Italy,   Japan,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00339183
Other Study ID Numbers  ICMJE 20050181
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amgen
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Amgen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP