Clinical trial · Interventional
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
NCT00582582CI-TRIAL-00042246terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of drug supply for doxercalciferol for this study
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel plus doxercalciferol | Drug | — | UNRESOLVED |
| Docetaxel plus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Docetaxel plus doxercalciferol
- interventionNames
- Drug: Docetaxel plus doxercalciferol
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Docetaxel plus placebo
- interventionNames
- Drug: Docetaxel plus placebo
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- At 12 weeks on study
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.