Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Unresectable disease Metastatic or recurrent disease Not amenable to potentially curative treatment No untreated leptomeningeal or brain metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 No known uncontrolled coagulopathy Hepatic AST and ALT < 2.5 times upper limits of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin < 2.0 times ULN Renal Creatinine clearance > 40 mL/min Urine protein negative Urine protein:creatinine ratio > 1 Cardiovascular No unstable or uncontrolled hypertension (i.e., blood pressure [BP] > 150/100 mm Hg despite antihypertensive therapy) Patients who recently started or have adjusted antihypertensive medications are eligible provided BP is < 140/90 mm Hg for ≥ 3 different measurements over 14 days No arterial thromboembolic events within the past 6 months, including any of the following: Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction Clinically significant peripheral vascular disease No New York Heart Association class III-IV congestive heart failure No uncontrolled symptomatic coronary artery disease or cardiac arrhythmia No other significant uncontrolled cardiac disease Gastrointestinal No lack of physical integrity of the upper gastrointestinal tract No malabsorption syndrome No inability to tolerate oral medication Immunologic No prior severe infusion reaction to a monoclonal antibody No history of an allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, cetuximab, capecitabine, or bevacizumab No prior unanticipated, severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluoroucacil Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during the study and for 3-4 months after completion of study treatment No peripheral neuropathy ≥ grade 2 No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix No known dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: Biologic therapy No prior adjuvant bevacizumab or cetuximab No other concurrent anticancer immunotherapy or biologic therapy Chemotherapy At least 6 months since a prior adjuvant fluorouracil-, leucovorin calcium-, or capecitabine-based regimen At least 12 months since prior adjuvant oxaliplatin No prior chemotherapy for metastatic or recurrent disease Endocrine therapy No concurrent hormonal therapy Radiotherapy No concurrent radiotherapy Surgery More than 4 weeks since prior major surgery and recovered More than 6 months since vascular surgery, stenting, or angioplasty Other At least 4 weeks since prior and no concurrent sorivudine or brivudine More than 4 weeks since prior participation in any investigational drug study No prior therapy that affects or targets the epidermal growth factor pathway No concurrent cimetidine Concurrent ranitidine, famotidine, or proton-pump inhibitors allowed Concurrent anticoagulation therapy with full-dose anticoagulant allowed provided dose is stable for at least 2 weeks
Sites / Locations
- Duke Comprehensive Cancer Center
- Wake Forest University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.