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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00697437 |
Primary Objective:
Secondary Objective:
Condition | Intervention | Phase |
---|---|---|
Solid Tumors |
Drug: Docetaxel, Ketoconazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind |
Official Title: | Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel |
Study Start Date: | October 2006 |
Introduction: This is a follow-up protocol to an earlier study entitled "A phase I study of docetaxel with ketoconazole modulation in solid tumors" (PH14/01) which showed 2-fold reduction in docetaxel clearance and a clear correlation with renal function.
Aims: The aim of this study is to confirm that ketoconazole inhibition of CYP3A activity changes the urinary excretion profile of docetaxel.
Methodology: This is a single-centre, crossover study. Ten patients (calculated sample size =5, α=0.05, β=0.8, difference in means=5%, within group standard deviation=3) will be accrued and randomly assigned to receive docetaxel at either 75mg/m2 q3w x 1 dose or 70mg q3w x 1 dose with ketoconazole 200mg bid x q3d at cycle 1 of chemotherapy. This will be followed by a 20-day washout period before receiving the other regimen of docetaxel at cycle 2. Blood samples of 5mls each will be drawn at times 0, 0.5h, 1h, 1.5h, 3h, 4h, 6h and 24h after the onset of docetaxel infusion for pharmacokinetics analysis. A 24-hour urine collection commencing on the same day as docetaxel infusion will be required of the patients. All urine over the next 24 hours must be collected and returned to the study coordinator on Day 2 of each study cycle for docetaxel analysis and creatinine clearance determination. The amount of docetaxel excreted by each patient with and without ketoconazole modulation will be determined by a LCMSMS method and compared.
Clinical Relevance: This is to ensure the safe advocation of a dose-sparing strategy established in an earlier study for the costly agent docetaxel by confirming if changes in excretion profile occurs once its major route of hepatic metabolism is blocked.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal renal and marrow function as defined below:
Exclusion Criteria:
Contact: Boon Cher Goh, MBBS, MRCP | 65-6772-4617 | Boon_Cher_Goh@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Boon Cher Goh, MBBS, MRCP 65-6772-4617 Boon_Cher_Goh@nuh.com.sg | |
Principal Investigator: Boon Cher Goh, MBBS, MRCP |
Principal Investigator: | Boon Cher Goh, MBBS, MRCP | National University Hospital, Singapore |
Study ID Numbers: | PK01/01/06 |
Study First Received: | June 11, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00697437 |
Health Authority: | Singapore: Domain Specific Review Boards |
Docetaxel Clotrimazole Miconazole Tioconazole Ketoconazole |
Anti-Infective Agents Antineoplastic Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |