Cancer, advanced breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The study consist of two parts.
1. Part I is Proof of concept study. It consist of two groups of patients:
1.1. Group I is treated in the course 1 with a single oral dose of docetaxel with CsA and 3 w
Sponsors
The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) (Netherlands)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients must have: 1. Advanced breast cancer, measurable disease according to WHO criteria 2. Treatment with one anthracycline containing regimen, prior adjuvant chemotherapy is allowed 3. > 18 years 4. Life expectancy >3 months 5. No radiotherapy for at least 4 weeks prior to entry on study 6. WBC > 3.0x10^9/l, platelets > 100x10^9/l 7. WHO performance status 0-2 8. Written informed consent 9. Previous hormonal therapy, immunotherapy, or local radiotherapy (without compromising the indicator lesions is allowed) 10. No history of other neoplasm, except curatively treated nonmelanoma skin cancer and curatively treated carcinoma in situ of the cervix
Exclusion criteria
Exclusion criteria: 1. Concomitant use of MDR converting drugs, such as Ca+ - entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine, quinine, tamoxifen, megestrol 2. Uncontrolled infectious disease 3. Unresolved (> grade 1) toxicities of previous chemotherapy 4. Impaired renal function (serum creatinine > 160:mol/l, or clearance 20:mol/l 6. Serum albumin < 25g/l 7. Bowel obstruction or motility disorders that may influence the reabsorption of drugs 8. Use of H2-receptors antagonist or proton pump inhibitors 9. Childbearing or no adequate contraception 10. Neurologic disease that may render a patient at increased risk for peripheral or central neurotoxicity 11. Symptomatic cerebral or leptomeningeal metastases 12. Unable to give written informed consent 13. Unwilling or unable to undergo blood sampling for pharmacokinetics 14. No prior taxane therapy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy is estimated during the tumour evaluation (CT, X-rays and US) during the baseline and every second course according to WHO criteria. 2. In amendment 2 the mass balance part of the study has been added. Three evaluable patients who are enrolled in the part II study were asked to collect their urine and faeces up to 48 hours which will be further analyzed for docetaxel and metabolites using validated analytical assays. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Safety Assessments are performed during the baseline, every course/weekly and at the end of the treatment 1.1. Medical history 1.2. Physical examination 1.3. Performance status WHO 1.4. Haemoglobin (Hb) 1.5. White blood count (WBC) differential platelets 1.6. Chemistry 1.7. Chest X-ray 1.8. Tumour evaluation 2. Pharmakinetic (PK) analyses are determined on the first 2 occasions of drug administration | — |
Countries
Netherlands
Outcome results
None listed