A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer
All eligible patients will receive combined modality treatment initially. Systemic treatment
will begin 4-6 weeks after completion of the Combined Modality portion and will complete 4
cycles of a 4 week regimen. Patients with no evidence of disease following systemic therapy
may continue single agent bevacizumab for up to one year. After all treatment is completed,
patients will be re-evaluated with imaging to establish a new baseline. Patients will be
re-evaluated thereafter for up to a total of 5 years.
Combined Modality Treatment:
- bevacizumab 5mg/kg IV infusion days 1, 15, and 29
- fluorouracil 225mg/m2 IV continuous infusion days 1-42
- radiation 1.8 Gy/day or 28 fractions weeks 1-6
Systemic Treatment:
- 5-fluorouracil 400 mg/m2 bolus
- 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
- leucovorin 350 mg prior to FU on days 1 and 15
- oxaliplatin 85 mg/m2 days 1 and 15
- bevacizumab 5 mg/kg days 1 and 15
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
24 months
No
David R. Spigel, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI GI 65
NCT00308516
March 2006
February 2012
Name | Location |
---|---|
Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
Northeast Arkansas Clinic | Jonesboro, Arkansas 72401-3125 |
South Texas Oncology and Hematology | San Antonio, Texas 78229 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Consultants in Blood Disorders and Cancer | Louisville, Kentucky 40207 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Peninsula Cancer Institute | Newport News, Virginia 23601 |
Tennessee Oncology | Nashville, Tennessee 37203 |
Wellstar Cancer Research | Marietta, Georgia 30060 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |
Consultants in Medical Oncology and Hematology | Drexel Hill, Pennsylvania 19026 |
Chattanooga Oncology Hematology Associates | Chattanooga, Tennessee 37404 |