Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00339183
First received: June 16, 2006
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Panitumumab
Drug: FOLFIRI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Enrollment: 1186
Study Start Date: May 2006
Study Completion Date: November 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm 2
The comparator arm consists of panitumumab plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
Drug: FOLFIRI
The 'control' arm for this study consists of a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan.
Experimental: Treatment Arm 1
The experimental arm consists of panitumumab plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.
Drug: Panitumumab
Panitumumab is a fully human monoclonal antibody targetting the EGFr pathway
Drug: FOLFIRI
The 'control' arm for this study consists of a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or woman at least 18 years old
  • Diagnosis of metastatic colorectal cancer
  • One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
  • Radiologically documented disease progression per modified 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
  • 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 CNS metastases
  • History of another primary cancer within 5 years of randomization
  • Prior irinotecan therapy
  • Prior anti-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 CT scan
  • Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
  • Known positive tests for HIV, HCV, acute or chronic active 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339183

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00339183     History of Changes
Other Study ID Numbers: 20050181
Study First Received: June 16, 2006
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Oncology
Cancer
Metastatic Colorectal Cancer
EGFr
Panitumumab
Clinical Trial
Amgen

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014