A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Colorectal Cancer
Interventions
DRUG

bevacizumab [Avastin]

5 mg/kg intravenously every 2 weeks, 4 cycles

DRUG

capecitabine [Xeloda]

825 mg/m2 twice daily orally, 38 days

RADIATION

Radiation therapy

Total dose of 45 Gy over 38 days

PROCEDURE

Mesorectal excision

6-8 weeks after completion of neoadjuvant treatment

DRUG

bevacizumab [Avastin]

Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months

DRUG

5-fluorouracil

Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months

DRUG

leucovorin

Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

Trial Locations (9)

12100

Cuneo

16132

Genova

40139

Bologna

53100

Siena

56100

Pisa

60121

Ancona

80131

Napoli

87027

Paola

00135

Roma

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01227707 - A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer. | Biotech Hunter | Biotech Hunter