Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Terminated

CT.gov ID

NCT00582582

Collaborator

Sanofi (Industry), Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Docetaxel plus doxercalciferol Drug: Docetaxel plus placebo	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2002

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective response rate [At 12 weeks on study]

Secondary Outcome Measures

Safety [Duration of study participation through 30 days post last treatment dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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:

PSA >or= 10 ng/mL and at least one lesion on bone scan.
Soft tissue metastases and/or visceral disease per CT scan.

Must show progressing prostate cancer as seen by one of the following:

At least one new lesion on bone scan,
Increase in size or number of measurable disease lesions,
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).