Metastasized cervix carcinoma Cancer Malignant neoplasm of cervix uteri
Conditions
Interventions
Patients will be recruited in cohorts of three and the starting dose will be 100 mg. Based on dose limiting toxicity evaluations, decisions regarding dose escalation or de-escalation on the next cohor
Sponsors
Dafra Pharma Research and Development (Belgium)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females aged 18 years or above 2. Diagnosed with cervix carcinoma stages IIIb, IVa and IVb 3. Overall good general condition (Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2) 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindication to use of artesunate due to hypersensitivity 2. Pregnant at time of recruitment 3. Human immunodeficiency virus (HIV) positive 4. History of hearing or balance problems 5. Weight of less than 50 kg or greater than 100 kg 6. On concomitant medication known to interact with artesunate 7. The following laboratory values obtained within 14 days prior to recruitment: 7.1. Absolute neutrophil count (ANC) less than 1,000 cells/mm3 7.2. Haemoglobin lower than 9.0 g/dL 7.3. Platelet count less than 100,000/mm3 7.4. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), and alkaline phosphatase higher than 5 x upper limit of normal (ULN) 7.5. Total bilirubin higher than 1.5 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of maximum tolerated dose (defined as one dose level below that at which dose limiting toxicity [DLT] is observed in two or more of the patients), assessed during the treatment period of 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumour response and correlation to expression of markers in tumor biopsy samples, assessed after the treatment period of 28 days. | — |
Countries
Kenya
Outcome results
None listed