Phase I study of oral artesunate in colorectal cancer
| ISRCTN | ISRCTN05203252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05203252 |
| Secondary identifying numbers | 07.0195, protocol v2.3 (9 September 2008) |
- 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
Not provided at time of registration
Contact information
Prof Devinder Kumar
Scientific
Scientific
Department of Colorectal Surgery
St George's NHS Healthcare Trust
Blackshaw Road
London
SW17 0RS
United Kingdom
Study information
| Study design | Single-centre randomised double-blind placebo-controlled interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Phase I placebo controlled, randomised, double-blind tolerability and efficacy study of oral artesunate in patients with colorectal carcinoma |
| 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(s) | Wandsworth Research Ethics Committee approved on 18th March 2008 (ref: 08/H0803/3) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Artesunate |
| Primary outcome measure | 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 study start date | 01/03/2009 |
| Overall study end date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 22 subjects |
| 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 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
- England
- United Kingdom
Study participating centre
Department of Colorectal Surgery
London
SW17 0RS
United Kingdom
SW17 0RS
United Kingdom
Sponsor information
St George's, University of London (UK)
University/education
University/education
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| Website | http://www.sgul.ac.uk |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
University/education
St George's, University of London (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- St. George's
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
27/11/2015: Publication reference added.
