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
  Purpose

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
Prostate Cancer
Drug: Docetaxel plus doxercalciferol
Drug: Docetaxel plus placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: At 12 weeks on study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: April 2002
Study Completion Date: April 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582582

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792-5669
Sponsors and Collaborators
University of Wisconsin, Madison
Sanofi
Genzyme, a Sanofi Company
Investigators
Principal Investigator: George Wilding, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: George Wilding, MD, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00582582     History of Changes
Other Study ID Numbers: HSC 2001-484, CO01802
Study First Received: December 19, 2007
Last Updated: April 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Metastatic
Hormone Refractory
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dihydroxycholecalciferols
Hydroxycholecalciferols
1 alpha-hydroxyergocalciferol
Ergocalciferols
Docetaxel
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014