Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00582582
• Other study ID #: HSC 2001-484
• Secondary ID: CO01802
• Status: Terminated
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: April 2007

Study information

• Verified date: April 2009
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel plus doxercalciferol
Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
• Docetaxel plus placebo
Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Genzyme, a Sanofi Company, Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		At 12 weeks on study
Secondary	Safety		Duration of study participation through 30 days post last treatment dose