A Safety and Effectiveness Study of Pre-operative Artesunate in Stage II/III Colorectal Cancer

• Status: Active, not recruiting
• Trial end date: 2025-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety and effectiveness of pre-operative artesunate given orally once a day for 14 days prior to surgery in patients with Stage II/III colorectal cancer.

Artesunate is an established antimalarial drug with an excellent safety profile, is well tolerated and affordable. A number of laboratory studies and one small pilot clinical study in patients with colorectal cancer have shown that artesunate can reduce the proliferation and growth of cancer cells.

Two hundred patients diagnosed with Stage II/III operable colorectal cancer will be randomly allocated to receive oral artesunate 200mg daily or a matching placebo for 14 days prior to surgery. Patients will be followed up closely for 5 years to see if giving artesunate preoperatively reduces the risk of cancer recurring after surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St George's, University of London
• Treatments: Artemisinins; Artesunate

Criteria

Inclusion criteria

1. Aged 18 or over

2. Histologically proven single primary site colorectal adenocarcinoma or high grade dysplasia plus unequivocal radiological evidence of invasive cancer

3. Stage II/III colorectal cancer planned for surgical resection and no clinical indication for neoadjuvant preoperative chemotherapy/chemoradiation therapy

4. WHO performance status 0,1 or 2

5. Adequate full blood count: White Cell Count (WCC) >3.0 x 10^9 /l; Platelets >100 x 10^9/l; Haemoglobin (Hb) >80g/L

6. Adequate renal function: Glomerular Filtration Rate >30ml/min by Cockcroft-Gault formula

7. Adequate hepatobiliary function : Bilirubin < 3 x Upper limit normal

8. Female participants of child bearing potential must have a negative pregnancy test < 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention

9. Male participants with a partner of childbearing potential must agree to use adequate, medically approved contraceptive precautions during and for up to 6 weeks after the last dose of the study treatment intervention

10. Patient able and willing to provide written, informed consent for the study.

Exclusion criteria

1. Contraindication to the use of artesunate due to hypersensitivity

2. Pregnancy or lactation

3. Male or female participants unwilling to use an effective method of birth control (either hormonal in the form of contraceptive pill or barrier method of birth control accompanied by the use of a proprietary spermicidal foam/gel or film); or agreement of true abstinence from time to consent is signed until 6 weeks after the last dose of study treatment intervention (i.e. withdrawal, calendar, ovulation, symptothermal and post ovulation methods are not considered acceptable methods)

4. History of immunosuppression

5. History of hearing or balance problems

6. Weight < 52kg or > 110kg

7. Other planned intervention, apart from standard of care

8. Any other malignant disease diagnosis within the preceding 2 years with the exception of non-melanomatous skin cancer and carcinoma in situ

9. Lactose intolerance