DaVINCI

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.

Share

Trial Status

Completed

Cancer Type

Colorectal Cancer

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.

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

  1. 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.
  2. 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