Dual Targeting of Vascular Endothelial Growth Factor-A Together With Angiopoietins in Chemotherapy-naïve Metastatic Colorectal Cancer (Vengeance)
Recruitment status was Recruiting
This is a clinical trial investigating the effectiveness and safety of the combination of the study drugs bevacizumab and AMG386 in patients with advanced (metastatic) chemotherapy-naive bowel (colorectal) cancer. Chemotherapy has a significant impact in metastatic bowel cancer in terms of maintenance of quality of life and extension of survival. However, ultimately tumours will develop resistance to these agents and further treatment options are urgently required.
Angiogenesis is a process that results in the formation of new blood vessels. Similar to normal tissues, solid tumours require new blood vessels for growth and survival. Hence, drugs targeting angiogenesis may be useful treatment options for patients with bowel cancer.
AMG386 and bevacizumab act on 2 different pathways relevant to angiogenesis. There is evidence from laboratory and animal studies to suggest that such a combination could be useful as a cancer treatment. Previous studies in humans have shown that AMG386 and bevacizumab can be combined safely.. This study aims to evaluate the effectiveness and safety of the combination of AMG386 and bevacizumab in patients with advanced bowel cancer.
40 patients from approximately four hospitals in Australia will participate in this trial, with approximately 20 patients being enrolled at Austin Health. All participants will receive the same treatment.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Phase II Study Evaluating the Combination of Bevacizumab and AMG386 Without Chemotherapy as First Line Treatment of Advanced Colorectal Cancer|
- Disease control (ie non progression) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 3 monthly ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Drug: AMG386 and bevacizumab
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249521
|Contact: Effie Skrinosfirstname.lastname@example.org|
|Melbourne, Victoria, Australia, 3084|
|Contact: Effie Skrinos +61394963576 email@example.com|
|Principal Investigator: Niall Tebbutt|
|Study Chair:||Niall Tebbutt||Austin Health|