Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

NCT ID: NCT00582582

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2007-04-30

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.

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.

Conditions

Prostate Cancer

Keywords

Metastatic; Hormone Refractory; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Docetaxel plus doxercalciferol

Group Type: EXPERIMENTAL

Docetaxel plus doxercalciferol

Intervention Type: DRUG

Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day

B

Docetaxel plus placebo

Group Type: PLACEBO_COMPARATOR

Docetaxel plus placebo

Intervention Type: DRUG

Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day

Interventions

Docetaxel plus doxercalciferol

Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day

Intervention Type: DRUG

Docetaxel plus placebo

Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day

Intervention Type: DRUG

Other Intervention Names

Taxotere; Hectoral; 1a,hydroxyvitamin D2; 1a-OH-D2; 1a-hydroxyerocalciferol; Vitamin D analog; prodrug of 1a,25-dihydroxyvitamin D2; Taxotere

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Wilding, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

CO01802

Identifier Type: -

Identifier Source: secondary_id

HSC 2001-484

Identifier Type: -

Identifier Source: org_study_id