Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00582582
Recruitment Status : Terminated (Lack of drug supply for doxercalciferol for this study)
First Posted : December 28, 2007
Last Update Posted : October 2, 2015
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 19, 2007
December 28, 2007
October 2, 2015
April 2002
Not Provided
Objective response rate [ Time Frame: At 12 weeks on study ]
Same as current
Complete list of historical versions of study NCT00582582 on Archive Site
Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ]
Same as current
Not Provided
Not Provided
Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Experimental: A
    Docetaxel plus doxercalciferol
    Intervention: Drug: Docetaxel plus doxercalciferol
  • Placebo Comparator: B
    Docetaxel plus placebo
    Intervention: Drug: Docetaxel plus placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2007
Not Provided

Inclusion Criteria:

  • Histologic diagnosis of adenocarcinoma of the prostate.
  • evidence of metastatic disease within 4 weeks of registration.
  • Must meet ONE of the following:

    1. PSA >or= 10 ng/mL and at least one lesion on bone scan.
    2. Soft tissue metastases and/or visceral disease per CT scan.
  • Must show progressing prostate cancer as seen by one of the following:

    1. At least one new lesion on bone scan,
    2. Increase in size or number of measurable disease lesions,
    3. 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).
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
HSC 2001-484
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
  • Sanofi
  • Genzyme, a Sanofi Company
Principal Investigator: George Wilding, MD University of Wisconsin, Madison
University of Wisconsin, Madison
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP