Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

This study has been terminated.
(Lack of drug supply for doxercalciferol for this study)
Sponsor:
Collaborators:
Sanofi
Genzyme, a Sanofi Company
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582582
First received: December 19, 2007
Last updated: April 13, 2009
Last verified: April 2009

December 19, 2007
April 13, 2009
April 2002
Not Provided
Objective response rate [ Time Frame: At 12 weeks on study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00582582 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
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).
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00582582
HSC 2001-484, CO01802
Yes
George Wilding, MD, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
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