Phase I study of oral artesunate in colorectal cancer

ISRCTN	ISRCTN05203252
DOI	https://doi.org/10.1186/ISRCTN05203252
Protocol serial number	07.0195, protocol v2.3 (9 September 2008)
Sponsor	St George's, University of London (UK)
Funder	St George's, University of London (UK)

Submission date: 03/12/2008
Registration date: 16/01/2009
Last edited: 27/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Devinder Kumar
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-centre randomised double-blind placebo-controlled interventional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Phase I placebo controlled, randomised, double-blind tolerability and efficacy study of oral artesunate in patients with colorectal carcinoma
Study objectives	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(s)	Wandsworth Research Ethics Committee approved on 18th March 2008 (ref: 08/H0803/3)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Artesunate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	22
Key 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
Key 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
Date of first enrolment	01/03/2009
Date of final enrolment	01/03/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Colorectal Surgery

London
SW17 0RS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/11/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

27/11/2015: Publication reference added.