Trial information
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Status: No longer recruiting
Protocol number: ML18522
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the effect of combination treatment with Avastin and Xeloda, plus pre-operative standard radiotherapy, on response rate in patients with locally advanced rectal cancer.
Brief summary: This study will assess the efficacy and safety of treatment with Avastin (5mg/kg iv every 2 weeks for 4 courses) plus Xeloda (1650mg/m² po daily for 38 days) in combination with standard technique radiotherapy of the pelvic region in the pre-operative setting, in patients with locally advanced primary rectal cancer. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 43.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab[Avastin]
Primary outcome: 1. Pathological tumor assessment, and clincal tumor and lymph node assessment, after surgery, within 6-8 weeks after completion of chemo-radiotherapy.
Key secondary outcomes: 1. Adverse events, laboratory parameters.
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.
Exclusion criteria:
- prior radiotherapy or chemotherapy for rectal cancer;
- untreated brain metastases or primary brain tumors;
- chronic, daily treatment with high-dose aspirin (>325mg/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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: December, 2005
Trial registration date: 05/04/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Ancona
- Bologna
- Cuneo
- Genova
- Napoli
- Paola
- Pisa
- Roma
- Siena
