Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

Tracking Information
First Submitted Date ICMJE	December 19, 2007
First Posted Date ICMJE	December 28, 2007
Last Update Posted Date	October 2, 2015
Study Start Date ICMJE	April 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: December 27, 2007)	Objective response rate [ Time Frame: At 12 weeks on study ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00582582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 27, 2007)	Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
Official Title ICMJE	Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Drug: Docetaxel plus doxercalciferol Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day Other Names: Taxotere Hectoral 1a,hydroxyvitamin D2 1a-OH-D2 1a-hydroxyerocalciferol Vitamin D analog prodrug of 1a,25-dihydroxyvitamin D2; Drug: Docetaxel plus placebo Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day Other Name: Taxotere
Study Arms	Experimental: A Docetaxel plus doxercalciferol Intervention: Drug: Docetaxel plus doxercalciferol; Placebo Comparator: B Docetaxel plus placebo Intervention: Drug: Docetaxel plus placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: December 27, 2007)	70
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Histologic diagnosis of adenocarcinoma of the prostate.; evidence of metastatic disease within 4 weeks of registration.; Must meet ONE of the following: PSA >or= 10 ng/mL and at least one lesion on bone scan. Soft tissue metastases and/or visceral disease per CT scan.; Must show progressing prostate cancer as seen by one of the following: At least one new lesion on bone scan, Increase in size or number of measurable disease lesions, At least 2 rising PSA measurements at least two weeks apart.; Prior bilateral orchiectomy or on LHRH agonist therapy with a serum testosterone level of < 50.; Must be off flutamide, nilutamide, or ketoconazole or herbal supplements used to treat prostate cancer at least 4 weeks prior to registration and bicalutamide at least 6 weeks prior to registration.; No prior cytotoxic chemotherapy.; WHO performance status of 0-2.; Peripheral neuropathy must be < or = to grade 1. Exclusion Criteria: A history of a radiographically confirmed kidney stone or pathologically confirmed calcium stone within the last 10 years.; Patients can continue to take bisphosphonates during the study as long as the bisphosphonate was started at least 4 weeks prior to study entry and the patient continues to demonstrate a rising PSA; No prior treatment with suramin, strontium or other therapeutic radioisotopes.; No radiotherapy within the past 4 weeks.; No known brain metastases.; No chronic hypercalcemia (serum calcium >1.0 mg/dl above the upper limit of normal range), chronic gastrointestinal disease (malabsorption, surgery affecting absorption, chronic ulcerative colitis) or any condition that the investigator feels would put the patient at undue risk.; Must not be taking digitalis, thiazide diuretics (or drugs in combination with thiazides) or calcium supplements within one week of treatment initiation.; No active angina, known heart disease of New York Heart Association Class II-IV or a recent history (< 6 months) of myocardial infarction.; Must not be taking steroids, anticonvulsants, fluoride, or lithium.; Must not have urinary protein > 4gm/24 hours; Must not have urinary calcium > or= 500 mg/24 hours; No Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively).
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00582582
Other Study ID Numbers ICMJE	HSC 2001-484; CO01802
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Wisconsin, Madison
Study Sponsor ICMJE	University of Wisconsin, Madison
Collaborators ICMJE	Sanofi; Genzyme, a Sanofi Company
Investigators ICMJE	Principal Investigator: George Wilding, MD University of Wisconsin, Madison
PRS Account	University of Wisconsin, Madison
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP