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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Colorectal Cancer, Rectal Cancer, Metastatic Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

37 months

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Belgium: Directorate-General for Medicinal Products

Study ID:

20070509

NCT ID:

NCT00819780

Start Date:

February 2009

Completion Date:

March 2015

Related Keywords:

  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Metastatic Colorectal Cancer
  • Colon Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Panitumumab
  • Vectibix
  • modified FOLFOX 6
  • mFOLFOX 6
  • FOLFOX
  • Bevacizumab
  • Avastin
  • First-Line
  • metastatic
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteAshland, Kentucky  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington