Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00508404
First received: July 26, 2007
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

The purpose of this study is evaluate the treatment effect of panitumumab plus FOLFIRI as first line therapy in metastatic colorectal cancer.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: panitumumab
Drug: FOLFIRI
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Evaluated every 8 weeks through to week 48 of the study. Every 3 months thereafter until radiographic disease progression. ] [ Designated as safety issue: No ]
    Incidence of either a confirmed complete or partial response.


Enrollment: 154
Study Start Date: April 2007
Study Completion Date: June 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Single-arm: Panitumumab in combination with Irinotecan, 5-fluorouracil, Leucovorin (FOLFIRI)
Drug: panitumumab
6mg/kg panitumumab (IV) on day 1 of each 14 day treatment cycle just prior to administration of chemotherapy (FOLFIRI) . Number of cycles: until progression or unacceptable toxicity develops.
Other Name: Vectibix
Drug: FOLFIRI
On day 1 of each 14 day treatment cycle FOLFIRI is administered just after 6mg/kg panitumumab. Number of cycles : until progression or unacceptable toxicity develops

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with histologically- or cytologically-confirmed Metastatic adenocarcinoma of the colon and/or rectum.
  • Measurable disease according to modified RECIST guidelines.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
  • Adequate haematologic, renal, hepatic and metabolic function.

Exclusion Criteria:

  • Central nervous system metastases.
  • Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
  • Prior anti-EGFr antibody therapy (e.g.: cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib).
  • Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
  • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
  • History of Gilbert's syndrome or dihydropyrimidine deficiency.
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
  • Any investigational agent within 30 days before initiation of study treatment.
  • Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
  • Subject who is pregnant or breast-feeding.
  • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.

    • Other protocol specified criteria and specific details may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508404

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

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00508404     History of Changes
Other Study ID Numbers: 20060314, EUDRACT Number 2006-006739-36
Study First Received: July 26, 2007
Last Updated: November 1, 2013
Health Authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Belgium: Federal Agency for Medicines and Helath Products (FAMHP)

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
Fluorouracil
Antibodies, Monoclonal
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014