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Study Complete
Sponsor ID
20070509

PEAK: Panitumumab plus mFOLFOX6 vs. Bevacizumab plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients with Wild-Type Kirsten rat Sarcoma-2 virus (KRAS) Tumors

Sponsor ID
20070509
Clinicaltrials.gov ID
NCT00819780
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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 patients with tumors expressing wild-type KRAS, unresectable mCRC.

Additional Study Details

Phase
Phase 2
Product
panitumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
285
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-free survival (PFS)

Timeframe: 37 months

Secondary Outcome Measures

Overall survival (OS), objective response (OR), duration of response (DOR), time to progression (TTP), time to response (TTR) and resection rate

Timeframe: 53 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Charleroi, Belgium, 6000
Status
Recruiting
Location
Research Site
Libramont, Belgium, 6800
Status
Recruiting
Location
Research Site
Sint-Niklaas, Belgium, 9100
Status
Recruiting
Location
Research Site
Edegem, Belgium, 2650
Status
Recruiting
Location
Research Site
Bielefeld, Germany, 33611
Status
Recruiting
Location
Research Site
Regensburg, Germany, 93049
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Colon Cancer
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  • Colorectal Cancer
    • Sex
    All
    Trial Dates
    Apr 2009 - May 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease - Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (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.