Trial information
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer.
Status: Recruiting
Protocol number: ML21440
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to assess the effect on progression-free survival and disease response of Avastin + Xeloda as maintenance treatment, after initial combination treatment with Xeloda + oxaliplatin + Avastin in patients with metastatic colorectal adenocarcinoma
Brief summary: This 2 arm study will assess the efficacy and safety of maintenance treatment with Avastin + Xeloda, after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients will be randomized into one of 2 groups to receive 1)Xeloda + oxaliplatin + Avastin until disease progression or 2)Xeloda + oxaliplatin + Avastin for 6 x 3 week cycles, followed by Xeloda + Avastin until disease progression. Xeloda will be administered at a dose of 1000mg/m2 po bid on days 1-14 of each cycle, oxaliplatin at a dose of 130mg/m2 iv on day 1 of each cycle, and Avastin at a dose of 7.5mg/kg iv on day 1 of each cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 118.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall survival, overall response rate, time to response, duration of response, surgery with curative intent. Time frame: Event driven
2. AEs, laboratory parameters, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- histologically confirmed colon or rectal cancer, with unresectable metastatic disease;
- at least one measurable lesion;
- outpatient, with ECOG Performance Status 0-1.
Exclusion criteria:
- previous treatment with Avastin;
- previous systemic treatment for advanced or metastatic disease;
- clinically significant cardiovascular disease;
- daily chronic treatment with high doses of aspirin (>325mg/day) or NSAIDs.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2008
Trial registration date: 02/15/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Turkey
- Ankara
- Gaziantep
- Istanbul
- Izmir
