Oral bioavailability of docetaxel in combination with cyclosporin A and activity of the combination in advance breast cancer
- Conditions
- Cancer, advanced breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN90476883
- Lead Sponsor
- The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital (NKI/AVL) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 25
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
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 < 50ml/min)
5. Serum bilirubin > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety Assessments are performed during the baseline, every course/weekly and at the end of the treatment <br>1.1. Medical history<br>1.2. Physical examination<br>1.3. Performance status WHO<br>1.4. Haemoglobin (Hb)<br>1.5. White blood count (WBC) differential platelets<br>1.6. Chemistry<br>1.7. Chest X-ray<br>1.8. Tumour evaluation<br>2. Pharmakinetic (PK) analyses are determined on the first 2 occasions of drug administration
- Secondary Outcome Measures
Name Time Method 1. Efficacy is estimated during the tumour evaluation (CT, X-rays and US) during the baseline and every second course according to WHO criteria.<br>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.