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 - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00819780

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 II

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:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab Panitumumab

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

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:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00819780 History of Changes
Other Study ID Numbers:	20070509
Study First Received:	November 6, 2008
Last Updated:	January 19, 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
Panitumumab
Vectibix
modified FOLFOX 6

mFOLFOX 6
FOLFOX
Bevacizumab
Avastin
First-Line
metastatic

Additional relevant MeSH terms:

Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Bevacizumab
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 February 09, 2012