5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
Rectal Cancer, Cancer of the Rectum, Colorectal Cancer
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Cancer of the Rectum, Colorectal Cancer, Bevacizumab
Eligibility Criteria
Inclusion Criteria: Histologically confirmed Stage I or II rectal cancer Patients must be candidates for preoperative or adjuvant chemoradiation. Patients enrolling in the adjuvant chemoradiation cohort must have undergone surgical resection of the primary rectal tumor between 28 and 56 days (i.e., 4-8 weeks) prior to study treatment. ECOG performance status 0-1 Adequate bone marrow, liver, and kidney function At least 18 years of age Able to give written informed consent Exclusion Criteria: Treatment with prior chemotherapy or radiation for rectal cancer History of myocardial infarction Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease History of stroke within 6 months History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within 6 months Symptomatic sensory or peripheral neuropathy Prior treatment with anti-angiogenic agents Prior malignancy in the past 5 years Active infections or serious underlying medical condition Major surgery less than 28 days prior Women who are pregnant or lactating Thrombolytic therapy within 10 days of starting bevacizumab PEG tube, G-tube, or external biliary stents Proteinuria Non healing wound, ulcer or fracture History of bleeding diathesis or coagulopathy Hemoptysis Participation in another experimental trial within 28 days Uncontrolled anticoagulant therapy
Sites / Locations
- Northeast Alabama Regional Medical Center
- Northeast Arkansas Clinic
- Florida Cancer Specialists
- Integrated Community Oncology Network
- Watson Clinic Center for Cancer Care and Research
- Northeast Georgia Medical Center
- Wellstar Cancer Research
- Consultants in Blood Disorders and Cancer
- Consultants in Medical Oncology and Hematology
- Spartanburg Regional Medical Center
- Chattanooga Oncology Hematology Associates
- Tennessee Oncology
- South Texas Oncology and Hematology
- Peninsula Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A - Preoperative
Cohort B - Combined Modality
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6. At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6. Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.