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ISRCTN
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ISRCTN05203252
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ClinicalTrials.gov identifier
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Public title
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Phase I study of oral artesunate in colorectal cancer
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Scientific title
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Phase I placebo controlled, randomised, double-blind tolerability and efficacy study of oral artesunate in patients with colorectal carcinoma
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Acronym
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N/A
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Serial number at source
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07.0195, protocol v2.3 (9 September 2008)
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Wandsworth Research Ethics Committee approved on 18th March 2008 (ref: 08/H0803/3)
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Study design
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Single-centre randomised double-blind placebo-controlled interventional study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Colorectal adenocarcinoma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2009
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Anticipated end date
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01/03/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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22 subjects
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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St George's, University of London (UK)
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Trial website
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Publications
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Contact name
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Prof
Devinder
Kumar
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Address
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Department of Colorectal Surgery
St George's NHS Healthcare Trust
Blackshaw Road
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City/town
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London
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Zip/Postcode
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SW17 0RS
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Country
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United Kingdom
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Sponsor
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St George's, University of London (UK)
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Address
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Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Sponsor website:
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http://www.sgul.ac.uk
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Date applied
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03/12/2008
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Last edited
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16/01/2009
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Date ISRCTN assigned
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16/01/2009
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