Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Colorectal Neoplasms

About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring metastatic, colorectal, cancer, initial therapy
Eligibility Criteria
Inclusion Criteria: measurable metastatic adenocarcinoma of the colon or rectum no prior systemic therapy for metastatic disease adjuvant therapy must have been completed >/=12 months prior to recurrence, prior radiotherapy permitted but must have been completed > 6 months prior to study entry must have tumor tissue available for EGFR and thymidine phosphorylase evaluation ECOG PS 0-1 age >/= 18 adequate organ function: WBC>/=3,000, ANC >/=1,500, platelets>/= 100,000, total bilirubin </= 1.5X ULN, AST&ALT </= 2.5X ULN, create clearance >/= 50mL/min negative pregnancy test w/in 72 hours of treatment for women of child bearing potential ability to understand and willing to sign written ICF able to swallow and absorb oral medication Exclusion Criteria: medical or psychiatric condition which would potentially pose risk to patient by participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS disease, pregnancy or nursing) history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of cervix) w/in 5 years surgical procedure (not including closed biopsy or access port placement), open biopsy, significant traumatic injury w/in 28 days of registration or anticipation of need for surgical procedure while on study, fine needle aspiration or core biopsy w/in 7 days of registration urine protein:creatinine ration >/=1.0 at screening evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation) prior severe infusion reaction to MAB or allergic reaction to capecitabine or oxaliplatin underlying neuropathy >/= grade 2 TIA or CVA w/in 6 months
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
Cetuximab, Oxaliplatin, Capecitabine
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle