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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 : December 13, 2019
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel plus doxercalciferol Drug: Docetaxel plus placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer
Study Start Date : April 2002
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: A
Docetaxel plus doxercalciferol
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

Placebo Comparator: B
Docetaxel plus placebo
Drug: Docetaxel plus placebo
Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
Other Name: Taxotere

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: At 12 weeks on study ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00582582

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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792-5669
Sponsors and Collaborators
University of Wisconsin, Madison
Genzyme, a Sanofi Company
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Principal Investigator: George Wilding, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison Identifier: NCT00582582    
Other Study ID Numbers: HSC 2001-484
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: April 2009
Keywords provided by University of Wisconsin, Madison:
Hormone Refractory
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Vitamin D
1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents