SWOG clinical trial number
S0408

A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin and Bevacizumab for Resectable Colorectal Metastases in the Liver

Closed
Phase
Accrual
0%
Abbreviated Title
COLORECTAL
Activated
11/15/2006
Closed
04/01/2007
Participants
Limited: SWOG and ECOG Institutions Listed on the Title Page

Research committees

Gastrointestinal Cancer

Treatment

Oxaliplatin Bevacizumab Capecitabine

Eligibility Criteria Expand/Collapse

Colorectal cancer with resectable hepatic metastasis. Patients presenting with synchronous primary tumor and hepatic metastasis are eligible. Bilobar resection is permitted including atypical resections. Radiological evidence of liver mets with multiphasic contrast enhanced spiral CT scan. Patients with resectable primary colorectal cancer in place are eligible. No extrahepatic mets other than the primary site of tumor involvement. Within 28 days prior to reg: spiral CT; chest x-ray or CT of chest. Spiral CT must be available to submit for central review. No colonoscopy or fine needle aspiration within 7 days prior to reg. Must be willing to have materials submitted for central path review, translational medicine studies and central radiology review. Measurable disease. Exams for measurable disease done within 28 days prior to reg; exams for non-measurable disease done within 42 days prior to reg. PET scan within 21 days prior to reg. No prior treatment of metastatic disease. No adjuvant chemo for the primary tumor within 6 months prior to reg. No major invasive surgical procedure or open biopsy within 28 days prior to reg. Within 28 days prior to reg: hemoglobin >/= 9 g/dL; WBC >/= 3,000/mcl; platelets >/= 100,000/mcl; ANC >/= 1,500/mcl; estimated creatinine clearance >/= 60 cc/min; UPC ratio < 1 (or a 24-hour urine collection for assessment of protein must demonstrate < 1,000 mg of protein/24 hours); bilirubin </= 2xIULN; SGOT or SGPT </= 2.5xIULN. Zubrod </= 1. No uncontrolled hypertension. No peripheral neuropathy or peripheral vascular disease >/= Grade 2. No recent arterial thromboembolic event. Must not be receiving oral anticoagulation for treatment of thrombosis (warfarin 1 mg for patency of central venous catheter is allowed). Must not be pregnant or nursing; must agree to use effective contraceptive method. No prior malignancy except adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.