drugset / Trial / NCT01227707
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
Timeline
- Start
- 2005-11
- Primary completion
- 2010-08
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Background | Leucovorin | Small molecule | 100 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | — |
| Background | fluorouracil | Small molecule | 600 mg/m2 | — |