Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically* or cytologically* confirmed colorectal cancer Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery Metastatic disease NOTE: *Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of > 5 years has elapsed between initial primary surgery and the development of metastases Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known curative therapy exists No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases) PATIENT CHARACTERISTICS: Age 70 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL No bleeding diathesis or coagulopathy Hepatic Bilirubin normal AST and ALT ≤ 3 times upper limit of normal (ULN) INR < 1.5 (unless on therapeutic anticoagulants) No unstable or uncompensated hepatic disease Renal Creatinine < 1.2 times ULN OR Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Cardiovascular No history of stroke No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication) No myocardial infarction within the past year No New York Heart Association class II-IV congestive heart failure No unstable angina No serious cardiac dysrhythmia requiring medication No other clinically significant cardiovascular disease No other unstable or uncompensated cardiac disease Pulmonary No unstable or uncompensated respiratory disease Other Fertile patients must use effective contraception Able to receive oral medication No known hypersensitivity to fluorouracil or capecitabine No known dihydropyrimidine dehydrogenase deficiency No seizures not controlled by standard medical therapy No serious nonhealing wound, ulcer, or bone fracture No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix No other severe or uncontrolled systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy No prior bevacizumab Chemotherapy Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered > 6 months before the development of metastatic disease No prior chemotherapy for metastatic colon cancer No prior irinotecan or oxaliplatin Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics More than 28 days since prior and no concurrent major surgery More than 28 days since prior open biopsy More than 7 days since prior fine needle aspiration or core biopsy Other More than 4 weeks since prior and no concurrent participation in another experimental drug study More than 30 days since prior non-approved or investigational drugs
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
Arm 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7