News

2008

November 2008

AspECT

AspECT is drawing to the end of its recruitment phase. In this last push to get the total recruitment to 2500, we need each site to recruit just 4 patients - i.e. 2 per month. This is easily achievable.

Please note that for drug resupply over Christmas and New Year, all orders must be placed by 19^th Dec 2008 (17^th Dec 208 for Northern Ireland). Normal service will resume on 05 Jan 2009.

Please do not send any samples from Friday 19 December 2008 until Friday 02 January 2009.

October 2008

AspECT at the DSMC

The DSMC met on 26th September 2008 and were optimistic about recruitment and could see no reason from a data and safety viewpoint for the trial not to continue.

EnROL Recruitment

EnROL has now 3 active sites and 3 patients recruited.

COG

COG has received MHRA -CTA Approval and a Provisional Favourable Ethics Opinion, awaiting Final Approval. Site set-up is in progress.

SCOT

We have been requested by the Sponsor of the study to highlight to all recruiting sites a recent protocol violation concerning the dose of capecitabine given to patients over the age of 70. The protocol states 'Patients >/= 70 years and or patients < 70 years with a creatinine clearance 30-50 mls/min will commence treatment with capecitabine at 75% of the full dose.' Please ensure this is checked and adhered to for all patients you are currently treating or will be treating in the future.

September 2008

VICTOR at ESMO 2008

A presentation looking at recurrence rates in VICTOR patients according to COX-2 genotyping has been accepted for presentation at this year's ESMO conference in Stockholm (12-16 Sept 2008).

Click here to view the poster – PDF-File, 60.6 KB

February 2008

QUASAR 2 breaks all-time monthly recruitment record in January 2008!

January 2008 saw what we hope will be the start of good things to come. 70 patients were randomised into the study besting our previous record of 51. A big ‘thank you’ goes out to everyone for their efforts.

We have now randomised over a third of our total patient target and we hope that this success can continue as we move into our last full year of recruitment.

OCTO's New Address - effective from 18th January 2008

Oncology Clinical Trials Office (OCTO)
Department of Clinical Pharmacology
Old Road Campus Research Building
University of Oxford
Old Road Campus
off Roosevelt Drive
Headington
Oxford
OX3 7DQ

Tel: +44 (0) 1865 617000
Fax: +44(0) 1865 617010

2007

13th November 2007

Application of mobile phone technology for managing chemotherapy-associated side-effects

Background: Novel mobile phone technology linked to a serverthat communicates patients’ symptoms

Novel mobile phone technology linked to a server that communicates patients’ symptoms to healthcare professionals has been adapted to register the side- effects of chemotherapy and provide advice on management of toxicity. We report a feasibility study to examine the utility of home monitoring of patients’ symptoms via a mobile phone.

Methods:

Six colon cancer patients receiving adjuvant chemotherapy,entered symptom data onto user friendly screens on a mobile phone twice daily. This ‘real time’ self assessment of nausea,vomiting, mucositis, diarrhoea and hand–foot syndrome and measurement of temperature was sent via a secured connection to a remote computer. In the event of moderate or severe symptoms (generating amber and red alerts respectively), the nurse was immediately alerted by the computer, via a pager. The nurse then contacted the patient to reinforce the automatic advice sent to the patient on their phone and to assess the patient using clinical algorithms.

Results:

The patient used the mobile phones during the first two cycles of chemotherapy. The data were successfully analysed by the server software and alerts were generated alerting the study nurses to patients’ symptoms at the appropriate time.
There were 91 alerts—54 red and 37 amber; 54% (29/54) of the red alerts were data delay and transmission problems which were swiftly rectified. The remaining red alerts were managed appropriately by the study nurses. Both patients and staff felt confident in this approach to symptom management.

Conclusions:

This study demonstrates that the technology for monitoring patients’ symptoms worked well.
The patients felt secure in the knowledge that their symptoms were being closely monitored and that they were participating effectively in their own care management.

Click here to see the full article

30th August 2007

AspECT

The FDA communication on omeprazole and esomeprazole

Following their report to the FDA, AstraZeneca has provided data to two members of the AspECT trial management group (TMG) on the association between the use of omeprazole or esomeprazole and cardiac events. Concern was generated when one European randomized trial comparing omeprazole with surgery for gastro-esophageal reflux appeared to show a greater number of patients with cardiac events in those treated with omeprazole during a maximum of 14 years follow-up. The excess events seemed to occur within the first 2-3 years. A retrospective analysis of 12 randomized controlled trials of omeprazole compared to placebo revealed no trend towards increased cardiac events in those treated with omeprazole over 6-24 months follow-up. Another randomized trial comparing esomeprazole with laparoscopic surgery for gastro-esophageal reflux disease did not find any difference in the number of cardiac events between the two groups and this was also the finding of 10 placebo controlled randomized controlled trials of esomeprazole with at least 6 months follow-up.

It is the conclusion of the AspECT TMG that the body of evidence shows no association between omeprazole or esomeprazole and risk of cardiac events. There were a number of methodological problems that threaten the validity of the trials as the studies were not designed to address cardiovascular end points. Furthermore given the number of negative studies, the apparent increase in cardiac events seen in one trial was probably a chance finding. The continued evaluation of the safety of all drugs is important but when a large number of secondary analyses are done in search of potential harms, then apparent numerical differences will occasionally be seen by chance. The TMG believe this is an example of such a chance finding but will continue to review further data as they become available.

Click here for the full FDA statement

26th July 2007

VICTOR

Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectal Cancer N Engl J Med 357;4 July 26, 2007

It is too early to comment on the benefit of Vioxx® [rofecoxib] in preventing recurrences from colorectal cancer. The VICTOR study (Vioxx In Colorectal cancer Therapy: definition of Optimal Regime) confirms that the two-fold increase in risk of adverse cardiovascular events reported in Vioxx® clinical trials applies in patients with colorectal cancer. Our results have implications when selecting patients for treatment with Cox-2 inhibitors, but it has to be remembered that improved treatment for colorectal cancer is badly needed. By far the commonest cause of death to be expected in these patients in the decade following cancer treatment is from recurrence of their cancers, and not from cardiovascular disease.
Examination of risks of cardiovascular events at different periods during the trial is impeded because the overall numbers of patients with such events were low relative to the total numbers of patients treated. Also, because the trial was stopped prematurely there were too few patients completing full treatment courses to allow confident conclusions about risks late in treatment.

Statement by Professors David Kerr (University of Oxford) and Michael Langman (University of Warwick)

Click here for full article