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.
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.
- 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.
- 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