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Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT00582582•University of Wisconsin, Madison

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+4 more criteria

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
+2 more criteria

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Key Dates

Start Date

April 1, 2002

Completion Date

April 1, 2007

Last Updated

December 13, 2019

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Docetaxel plus doxercalciferol

DRUG

Docetaxel plus placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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