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Sponsors and Collaborators: |
University of Wisconsin, Madison Sanofi-Aventis Genzyme |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00582582 |
The purpose of this research study is to find out the toxicities of doxercalciferol given in combination with docetaxel (Taxotere®), as well as to see how well this combination works in the treatment of prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Docetaxel plus doxercalciferol Drug: Docetaxel plus placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer |
Enrollment: | 70 |
Study Start Date: | April 2002 |
Study Completion Date: | April 2007 |
Arms | Assigned Interventions |
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A: Experimental
Docetaxel plus doxercalciferol
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Drug: Docetaxel plus doxercalciferol
Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
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B: Placebo Comparator
Docetaxel plus placebo
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Drug: Docetaxel plus placebo
Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
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This is a multi-institutional, double-blinded, randomized study comparing docetaxel plus doxercalciferol versus docetaxel plus placebo in patients with metastatic hormone refractory prostate cancer. Docetaxel is given intravenously on days 1, 8 and 15 for every 28 day cycle and doxercalciferol or placebo is taken orally every day of the 28 day cycle. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must meet ONE of the following:
Must show progressing prostate cancer as seen by one of the following:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792-5669 |
Principal Investigator: | George Wilding, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( George Wilding, MD ) |
Study ID Numbers: | HSC 2001-484, CO01802 |
Study First Received: | December 19, 2007 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00582582 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Hormone Refractory Prostate Cancer |
Genital Neoplasms, Male Prostatic Diseases Ergocalciferol Ergocalciferols Bone Density Conservation Agents Trace Elements Urogenital Neoplasms Genital Diseases, Male Dihydroxycholecalciferols Hormones |
Hydroxycholecalciferols Docetaxel 1 alpha-hydroxyergocalciferol Vitamin D Vitamin D2 Vitamins Calciferol Micronutrients Prostatic Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Ergocalciferols Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male Dihydroxycholecalciferols |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site 1 alpha-hydroxyergocalciferol Therapeutic Uses Vitamins Micronutrients Prostatic Neoplasms |