Colon Cancer Clinical Trial
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
Summary
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.
Eligibility 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.
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There are 95 Locations for this study
Birmingham Alabama, 35205, United States
Huntsville Alabama, 35805, United States
Berkeley California, 94704, United States
Beverly Hills California, 90211, United States
Burbank California, 91505, United States
Fountain Valley California, 92708, United States
La Verne California, 91750, United States
Orange California, 92868, United States
Riverside California, 92501, United States
Roseville California, 95661, United States
Denver Colorado, 80218, United States
Stamford Connecticut, 06902, United States
Waterbury Connecticut, 06708, United States
Boynton Beach Florida, 33435, United States
Coral Springs Florida, 33065, United States
Daytona Beach Florida, 32114, United States
Hollywood Florida, 33021, United States
Lake Worth Florida, 33467, United States
Alpharetta Georgia, 30005, United States
Augusta Georgia, 30901, United States
Savannah Georgia, 31405, United States
Post Falls Idaho, 83854, United States
Gurnee Illinois, 60031, United States
Peoria Illinois, 61615, United States
Indianapolis Indiana, 46237, United States
Overland Park Kansas, 66210, United States
Wichita Kansas, 67214, United States
Danville Kentucky, 40422, United States
Hazard Kentucky, 41701, United States
Paducah Kentucky, 42003, United States
Baltimore Maryland, 21204, United States
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02111, United States
Kalamazoo Michigan, 49048, United States
Lambertville Michigan, 48144, United States
Lansing Michigan, 48912, United States
Mountain Lakes New Jersey, 07046, United States
Sparta New Jersey, 07871, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14215, United States
East Setauket New York, 11733, United States
Staten Island New York, 10301, United States
Huntersville North Carolina, 28078, United States
Raleigh North Carolina, 27607, United States
Akron Ohio, 44304, United States
Columbus Ohio, 43228, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19106, United States
Greenville South Carolina, 29605, United States
Mount Pleasant South Carolina, 29464, United States
Memphis Tennessee, 38120, United States
Austin Texas, 78759, United States
Corpus Christi Texas, 78463, United States
Dallas Texas, 75231, United States
Round Rock Texas, 78665, United States
Temple Texas, 76508, United States
Tyler Texas, 75702, United States
White River Junction Vermont, 05009, United States
Chesapeake Virginia, 23320, United States
Newport News Virginia, 23601, United States
Newport News Virginia, 23606, United States
Spokane Washington, 99218, United States
Vancouver Washington, 98684, United States
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Libramont , 6800, Belgium
Sint-Niklaas , 9100, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Victoria British Columbia, V8R 6, Canada
Oshawa Ontario, L1G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2X 3, Canada
Quebec , G1R 2, Canada
Berlin , 13125, Germany
Bielefeld , 33611, Germany
Magdeburg , 39104, Germany
München , 81737, Germany
München , 81925, Germany
Passau , 94032, Germany
Regensburg , 93049, Germany
Würzburg , 97070, Germany
Alba (CN) , 12051, Italy
Fano , 61032, Italy
Genova , 16132, Italy
Mantova , 46100, Italy
Udine , 33100, Italy
Varese , 21100, Italy
Málaga AndalucÃ-a, 29010, Spain
Santander Cantabria, 39008, Spain
Sabadell Cataluña, 08208, Spain
Elche Comunidad, 03203, Spain
A Coruña Galicia, 15006, Spain
San Sebastián De Los Reyes Madrid, 28702, Spain
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