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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/31/2018
Start Date:April 24, 2009
End Date:July 7, 2016

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
63
sites
Huntersville, North Carolina 28078
2099
mi
from 91732
Huntersville, NC
Click here to add this to my saved trials
2040
mi
from 91732
Akron, OH
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
1920
mi
from 91732
Alpharetta, GA
Click here to add this to my saved trials
2053
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
1213
mi
from 91732
Austin, TX
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
354
mi
from 91732
Berkeley, CA
Click here to add this to my saved trials
2277
mi
from 91732
Bethesda, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2309
mi
from 91732
Boynton Beach, FL
Click here to add this to my saved trials
2180
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
19
mi
from 91732
Burbank, CA
Click here to add this to my saved trials
5628
mi
from 91732
Charleroi,
Click here to add this to my saved trials
2340
mi
from 91732
Chesapeake, VA
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
2304
mi
from 91732
Coral Springs, FL
Click here to add this to my saved trials
1293
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1867
mi
from 91732
Danville, KY
Click here to add this to my saved trials
2187
mi
from 91732
Daytona Beach, FL
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
2479
mi
from 91732
East Setauket, NY
Click here to add this to my saved trials
Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Greenville, South Carolina 29605
2019
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
1720
mi
from 91732
Gurnee, IL
Click here to add this to my saved trials
1955
mi
from 91732
Hazard, KY
Click here to add this to my saved trials
2295
mi
from 91732
Hershey, PA
Click here to add this to my saved trials
2315
mi
from 91732
Hollywood, FL
Click here to add this to my saved trials
1785
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
1840
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
14
mi
from 91732
La Verne, CA
Click here to add this to my saved trials
2308
mi
from 91732
Lake Worth, FL
Click here to add this to my saved trials
1933
mi
from 91732
Lambertville, MI
Click here to add this to my saved trials
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
1586
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
2187
mi
from 91732
Mount Pleasant, SC
Click here to add this to my saved trials
2409
mi
from 91732
Mountain Lakes, NJ
Click here to add this to my saved trials
2326
mi
from 91732
Newport News, VA
Click here to add this to my saved trials
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
1335
mi
from 91732
Overland Park, KS
Click here to add this to my saved trials
1659
mi
from 91732
Paducah, KY
Click here to add this to my saved trials
1618
mi
from 91732
Peoria, IL
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
944
mi
from 91732
Post Falls, ID
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
31
mi
from 91732
Riverside, CA
Click here to add this to my saved trials
368
mi
from 91732
Roseville, CA
Click here to add this to my saved trials
1208
mi
from 91732
Round Rock, TX
Click here to add this to my saved trials
2131
mi
from 91732
Savannah, GA
Click here to add this to my saved trials
2398
mi
from 91732
Sparta, NJ
Click here to add this to my saved trials
939
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
2455
mi
from 91732
Stamford, CT
Click here to add this to my saved trials
2428
mi
from 91732
Staten Island, NY
Click here to add this to my saved trials
1218
mi
from 91732
Temple, TX
Click here to add this to my saved trials
1315
mi
from 91732
Tyler, TX
Click here to add this to my saved trials
835
mi
from 91732
Vancouver, WA
Click here to add this to my saved trials
2479
mi
from 91732
Waterbury, CT
Click here to add this to my saved trials
2511
mi
from 91732
White River Junction, VT
Click here to add this to my saved trials
1182
mi
from 91732
Wichita, KS
Click here to add this to my saved trials