Trial information
A Study of Avastin (Bevacizumab) and Oxalplatin Plus Xeloda (Capacitabine) in Patients With Advanced Colorectal Cancer.
Status: No longer recruiting
Protocol number: ML18523
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 oxaliplatin (Xelox)on response rate in patients with advanced colorectal cancer.
Brief summary: This study will assess the efficacy and safety of treatment with Avastin (5mg/kg iv every 2 weeks), Xeloda (2000mg/m² po daily) and oxaliplatin (40mg/m² iv weekly) in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 49.
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. Complete and partial tumor response rate.
Key secondary outcomes: 1. Efficacy: Duration of response, time to progression, overall survival. Safety: Adverse events, laboratory parameters.
Inclusion criteria:
- adult patients >=18 years of age;
- patients with confirmed colorectal cancer;
- locally advanced or metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease;
- measurable and/or evaluable lesions.
Exclusion criteria:
- radiotherapy within 4 weeks before study;
- untreated brain metastases or primary brain tumors;
- chronic, daily treatment with high-dose aspirin (>325mg/day);
- 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: January, 2006
Trial registration date: 05/04/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Aviano
- Fano
- Palermo
- Rimini
- Roma
