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

Roche

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Procedure: Mesorectal excision

Radiation: Radiation therapy

Drug: leucovorin

Drug: 5-fluorouracil

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01227707

ML18522

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >=18 years of age
Patients with confirmed rectal cancer who are subject to surgery and would benefit from pre-operative combined chemo-radiotherapy
Measurable and/or evaluable lesions according to RECIST criteria
EOCG performance status 0-1

Exclusion criteria

Prior radiotherapy or chemotherapy for rectal cancer
Untreated brain metastases or spinal cord compression or primary brain tumors
Chronic daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ.