Condition category
Cancer
Date applied
03/12/2008
Date assigned
16/01/2009
Last edited
27/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Devinder Kumar

ORCID ID

Contact details

Department of Colorectal Surgery
St George's NHS Healthcare Trust
Blackshaw Road
London
SW17 0RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07.0195, protocol v2.3 (9 September 2008)

Study information

Scientific title

Phase I placebo controlled, randomised, double-blind tolerability and efficacy study of oral artesunate in patients with colorectal carcinoma

Acronym

Study hypothesis

The primary objective of the study is to determine the anti-cancer effect of oral artesunate in colorectal adenocarcinoma defined as the proportion of malignant cells undergoing apoptosis.

Secondary outcome measures are to establish the tolerability of oral artesunate in colorectal cancer.

Ethics approval

Wandsworth Research Ethics Committee approved on 18th March 2008 (ref: 08/H0803/3)

Study design

Single-centre randomised double-blind placebo-controlled interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal adenocarcinoma

Intervention

Subjects will be randomised to receive 200 mg artesunate or placebo orally once daily for 14 days whilst awaiting surgery for colorectal adenocarcinoma with curative intent.

Intervention type

Drug

Phase

Phase I

Drug names

Artesunate

Primary outcome measures

A significant difference in the proportion of cells that exhibit apoptosis between the two treatment groups (placebo and artesunate), assessed at the time of surgery, after two weeks of drug treatment.

Secondary outcome measures

1. Tolerability of artesunate compared with placebo. Tolerability will be assessed according to conventional criteria used in clinical trials, and scored on standardised pro-formas.
2. Comparisons will also be made between baseline haematological and biochemical variables (full blood count, liver function tests, urea and electrolytes), and these measures repeated once treatment stops and before surgery

Assessed after one week and at the end of drug treatment.

Overall trial start date

01/03/2009

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 21 - 80 years, male or female
2. With biopsy confirmed single primary site colorectal adenocarcinoma
3. With stages I - IIIb (defined according to conventional criteria)
4. With planned curative resection
5. With written, informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

22 subjects

Participant exclusion criteria

1. Contraindication to use of artesunate due to hypersensitivity
2. Pregnancy (of any stage)
3. History of hearing or balance problems
4. Immunosuppression or concomitant medication known to interact with artesunate
5. Weight less than 50 kg or greater than 100 kg
6. Severe anaemia (haemoglobin less than 8 g/dl)
7. Other planned intervention, apart from standard of care
8. Inability to give informed consent
9. Inability or unwillingness to take effective contraception in women of child-bearing age
10. Chronic kidney disease of NKF D/QOFI stage 3 or above (estimated glomerular filtration rate [eGFR] less than 60 ml/min)
11. Bilirubin greater than 2 x upper limit of normal in the absence of haemolysis, or known chronic liver disease

Recruitment start date

01/03/2009

Recruitment end date

01/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Colorectal Surgery
London
SW17 0RS
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

http://www.sgul.ac.uk

Funders

Funder type

University/education

Funder name

St George's, University of London (UK)

Alternative name(s)

St. George's

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26137537

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.