Prostate Cancer
Conditions
Keywords
Metastatic, Hormone Refractory, Prostate Cancer
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.
Interventions
DRUGDocetaxel plus doxercalciferol
Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day
DRUGDocetaxel plus placebo
Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day
Sponsors
Sanofi
Genzyme, a Sanofi Company
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | At 12 weeks on study |
Secondary
| Measure | Time frame |
|---|---|
| Safety | Duration of study participation through 30 days post last treatment dose |
Countries
United States
Outcome results
None listed