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.

View Eligibility Criteria

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.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

285

Study ID:

NCT00819780

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 95 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

285

Study ID:

NCT00819780

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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