Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer

NCT00582582 | Terminated Phase 2 DMC

• 2 other identifiers: HSC 2001-484CO01802
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Metastatic; Hormone Refractory; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  At 12 weeks on study

Secondary Outcomes (1)

• Safety

  Duration of study participation through 30 days post last treatment dose

Study Arms (2)

A

EXPERIMENTAL

Docetaxel plus doxercalciferol

Drug: Docetaxel plus doxercalciferol

B

PLACEBO COMPARATOR

Docetaxel plus placebo

Drug: Docetaxel plus placebo

Interventions

Docetaxel plus doxercalciferol DRUG

Docetaxel 35mg/m2 IV weekly x3 every 4 weeks plus Doxercalciferol 10mcg orally every day

Also known as: Taxotere, Hectoral, 1a,hydroxyvitamin D2, 1a-OH-D2, 1a-hydroxyerocalciferol, Vitamin D analog, prodrug of 1a,25-dihydroxyvitamin D2

A

Docetaxel plus placebo DRUG

Docetaxel 35mg/m2 IV weekly x3 every 4 week cycle plus placebo taken orally every day

Also known as: Taxotere

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Sanofi: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792-5669, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; 1 alpha-hydroxyergocalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• George Wilding, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: April 1, 2002
• Study Completion: April 1, 2007
• Last Updated: December 13, 2019

Record last verified: 2009-04

Locations

US (1)