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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00212095 |
Patients with locally advanced or metastatic breast cancer and with measurable primary breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies and plasma samples will be taken for gene expression and proteomics studies to identify biomarkers that may predict for treatment response.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Docetaxel Combined With Ketoconazole in the First-Line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor |
Estimated Enrollment: | 30 |
Study Start Date: | June 2005 |
We hypothesize that 70mg docetaxel co-administered with ketoconazole would result in similar clinical efficacy as conventional doses of docetaxel (75mg/m2 body surface area) in terms of clinical and pathological response rates in metastatic breast cancer. We further hypothesize that tumor genomic and proteomic changes and serum proteomic changes would correlate with tumor response. We are also looking to correlate drug pharmacokinetics with treatment toxicity, genotype of drug metabolizing enzymes and transporters, and peripheral mononuclear cell gene expression profiles. The primary objectives are to evaluate the clinical response rate of 70mg docetaxel with ketoconazole in metastatic breast cancer, and to evaluate the pathological response rate in the primary tumor following four cycles of docetaxel and ketoconazole.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function including the following:
- Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L Platelets >= 100 x 109/L
- Hepatic: Bilirubin <= 1.5 x upper limit of normal (ULN), ALT or AST <= 2.5x ULN, (or <5 X with liver metastases)
- Renal: creatinine <= 1.5x ULN
Exclusion Criteria:
Contact: Soo-Chin Lee, MD | 65-6772-4621 | Lee_Soo_Chin@nuh.com.sg |
Contact: Boon-Cher Goh, MD | 65-6772-4621 | Goh_Boon_Cher@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Soo-Chin Lee, MD 65-6772-4621 Lee_Soo_Chin@nuh.com.sg | |
Contact: Boon-Cher Goh, MD 65-6772-4621 Goh_Boon_Cher@nuh.com.sg |
Principal Investigator: | Soo-Chin Lee, MD | Consultant |
Responsible Party: | ( Soo-Chin Lee, MD ) |
Study ID Numbers: | BR01/07/05 |
Study First Received: | September 13, 2005 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00212095 |
Health Authority: | Singapore: Health Sciences Authority |
breast cancer docetaxel gene expression proteomics |
Docetaxel Skin Diseases Clotrimazole Miconazole |
Tioconazole Breast Neoplasms Ketoconazole Breast Diseases |
Anti-Infective Agents Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antifungal Agents Pharmacologic Actions |