* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 5 years.
Adequate hematologic data as follows:
* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9 cells/L;
* Platelet count greater than or equal to 100 x 10\^9/L;
* Hemoglobin greater than or equal to 9.0 g/dL. - Adequate renal function:
* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN);
* Urinary protein dipstick of less than 2+ (if urinary dipstick 2+ or greater, then excretion of less than or equal to 1000 mg of protein per day as determined by 24-hour urine collection).
Adequate hepatic function:
* Alkaline phosphatase less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase)(AST) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Alanine aminotransferase (serum glutamic-pyruvic transaminase) (ALT) less than or equal to 3 x ULN (if liver metastases, less than or equal to 5 x ULN);
* Bilirubin less than or equal to 2 x ULN. - Competent to comprehend, sign, and date an IRB-approved informed consent form
Before any study-specific procedure, the appropriate written informed consent must be obtained.
You may not be if
Prior chemotherapy or biologic (i.e., antibody or vaccine) treatment for mCRC disease - Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before randomization - Radiotherapy within 14 days before randomization
Elective and/or planned major surgical procedure to be performed during the course of this trial (surgery that arises as needed or necessary during the course of the study, not agreed a priori, will not make the subject ineligible)
Major surgery within 28 days before randomization
Central nervous system metastases
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest X-ray or CT-scan
Clinically significant ascites
Preexisting bleeding diathesis or coagulopathy or the need for full-dose anticoagulation
Any of the following within 1 year before randomization:
* Myocardial infarction;
* Unstable angina;
* Symptomatic congestive heart failure;
* Serious uncontrolled cardiac arrhythmia;
* Cerebrovascular accident or transient ischemic attack;
* Gastrointestinal ulcer or hemorrhage;
* Hemoptysis;
* Pulmonary embolism;
* Deep vein thrombosis, or other significant thromboembolic event.
Regular use of non-steroidal anti-inflammatory agents
Female subject of childbearing potential, not abstinent, and not willing to use contraceptives during the course of the study and for 6 months following the last dose of first-line treatment
Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization
Male subject, not abstinent, and not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of first-line treatment
Subject known to be human immunodeficiency virus (HIV) positive
Subject allergic to panitumumab or any components of panitumumab formulation
History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
Subject unwilling or unable to comply with study requirements
Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
Clareo Health | PACCE: Panitumumab Advanced Colorectal Cancer Evaluation Study
