- DaVINCI
Trial Status
Completed
Cancer Type
Colorectal Cancer
Protocol Title
Randomised phase II trial of De Gramont schedule 5- fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer.
Purpose of the Study
Single agent Irinotecan and Irinotecan/5FU/LV combinations are frequently used second line regimens for patients with metastatic colorectal cancer, but it is unknown which is superior.
Principal Investigator
Prof Stephen Clarke
Funding
Pfizer Australia Pty Limited
DETAILED INFORMATION AVAILABLE
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here
Trial Status
Completed
Cancer Type
Colorectal Cancer
Publication Reference
Clarke SJ, Yip S, Brown C, van Hazel GA, Ransom DT, Goldstein D, Jeffrey GM, Tebbutt NC, Buck M, Lowenthal RM, Boland A, Gebski V, Zalcberg J, Simes RJ. Single-agent irinotecan or FOLFIRI as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis [corrected]. European Journal of Cancer 2011; 47(12): 1826–1836. 1
Conference Presentation Reference
- Clarke SJ, Brown C, Simes J, Van Hazel G, Jeffery M, Tebbutt N, Ransom D, Buck M, Boland A, Zalcberg J; Australasian Gastro-Intestinal Trials Group. AGITG DaVINCI Trial: Randomised phase II trial of De Gramont schedule 5-fluorouracil and leucovorin plus irinotecan versus single agent irinotecan in patients with previously treated metastatic colorectal cancer. Gastrointestinal Cancers Symposium; 15–17 Jan 2009; San Francisco.
- Brown C, Hudson M, Yip S, Clarke S, Gebski V. Incorporating historical control estimates into meta-analyses. Australian Statistical Conference; 9–12 Jul 2012; Adelaide.
Aim
Single agent Irinotecan and Irinotecan/5FU/LV combinations are frequently used second line regimens for patients with metastatic colorectal cancer, but it is unknown which is superior.
Summary
This study originally planned to recruit 300 patients with the primary end-point being tumour response. However, due to slower than expected recruitment, an amendment was proposed in September 2006 to revise the sample size and study end-points. This was approved on 20 June 2007 and the new protocol was sent to sites on the 26th July 2007.
The study closed to recruitment on 31 January 2008, having recruited a total of 89 patients
Protocol Amendment
As diarrhoea is the principal toxicity associated with both the single agent and combination regimens, it would therefore be useful to directly compare both and demonstrate a clinically significant difference in the rates of diarrhoea; the principal treatment limiting toxicity.
A revised sample size of 100 patients will allow, a comparison of rates of diarrhoea, side effects of treatment and the effect on patients’ quality of life. This study will also look at patients’ response to treatment and their overall survival.
Principal Investigator
Prof Stephen Clarke, Medical Oncologist, Concord Repatriation General Hospital, NSW
Funding
Pfizer Australia Pty Limited