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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Docetaxel plus doxercalciferol; Drug: Docetaxel plus placebo

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: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-5669
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	At 12 weeks on study

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety	Duration of study participation through 30 days post last treatment dose

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Sanofi; Genzyme, a Sanofi Company
• Investigators: Principal Investigator: George Wilding, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 27, 2007
• First Posted (Estimate): December 28, 2007

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Prostate Cancer; Metastatic; Hormone Refractory
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Micronutrients; Vitamins; Bone Density Conservation Agents; Docetaxel; Vitamin D; Dihydroxycholecalciferols; Hydroxycholecalciferols; 1 alpha-hydroxyergocalciferol
• Other Study ID Numbers: HSC 2001-484; CO01802