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PEAK: A Phase 2 Study of Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer Subjects With Wild-Type KRAS Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00819780
First received: November 6, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in subjects with tumors expressing wild-type KRAS, unresectable mCRC.


Condition Intervention Phase
Colon Cancer
Colorectal Cancer
Rectal Cancer
Metastatic Colorectal Cancer
 Drug: Panitumumab
Drug: Bevacizumab
Drug: mFOLFOX6
 Phase 2

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 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: 37 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS), objective response (OR), duration of response (DOR), time to progression (TTP), time to response (TTR) and resection rate [ Time Frame: 53 months ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: February 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Panitumumab plus mFOLFOX 6
 Drug: Panitumumab
Panitumumab is a fully human IgG2 monoclonal antibody antagonist directed against human Epidermal Growth Factor receptor (EGFr).
Other Name: Vectibix
Drug: mFOLFOX6
Oxaliplatin, Leucovorin, 5-FU IV Bolus, 5-FU IV Infusion
Active Comparator: Arm 2
Bevacizumab plus mFOLFOX 6
 Drug: Bevacizumab
Bevacizumab is a humanized monoclonal IgG1 antibody that is directed against Vascular Endothelial Growth Factor (VEGF). Bevacizumab, in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
Other Name: Avastin
Drug: mFOLFOX6
Oxaliplatin, Leucovorin, 5-FU IV Bolus, 5-FU IV Infusion

  Eligibility

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

Inclusion Criteria:

  • Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
  • Subjects with at least 1 uni-dimensionally measurable lesion of at least 10mm per modified RECIST guidelines
  • Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Men or women 18 years of age or older
  • Adequate hematologic, renal, hepatic, metabolic, and coagulation function

Exclusion Criteria:

  • History of prior or concurrent central nervous system (CNS) metastases
  • Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  • Clinically significant cardiac disease
  • Clinically significant peripheral sensory neuropathy
  • Active inflammatory bowel disease
  • Recent gastroduodenal ulcer to be active or uncontrolled
  • History of interstitial lung disease
  • Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  • Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  • Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819780

  Show 95 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00819780     History of Changes
Other Study ID Numbers: 20070509
Study First Received: November 6, 2008
Last Updated: July 12, 2012
Health Authority: Belgium: Directorate-General for Medicinal Products
Canada: Health Canada
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Italy: Local Ethics Committees
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
United States: Quorom Institutional Review Board
United States: Western Institutional Review Board

Keywords provided by Amgen:
Colon Cancer
Colorectal Cancer
Rectal Cancer
Bevacizumab
Avastin
Panitumumab
 Vectibix
modified FOLFOX 6
mFOLFOX 6
FOLFOX
First-Line
metastatic

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bevacizumab
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors

ClinicalTrials.gov processed this record on May 21, 2013