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Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN


Phase 2
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN


OBJECTIVES:

- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the
development of prostate cancer in patients with localized prostate cancer.

- Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one
of 2 arms.

- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo
prostatectomy.

- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed localized adenocarcinoma of the prostate

- Candidate for prostatectomy

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.4 mg/dL

- AST no greater than 3 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

- Calcium no greater than 10.2 mg/dL

- No idiopathic urinary calcium stone disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No prior hormonal therapy for prostate cancer

- No concurrent hormonal therapy, including luteinizing hormone-releasing hormone
agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride,
diethylstilbestrol, or progestins

Radiotherapy:

- No prior brachytherapy or external beam radiotherapy for prostate cancer

Surgery:

- See Disease Characteristics

Other:

- At least 7 days since prior vitamin D therapy or calcium supplements

- No other concurrent vitamin D analogues or calcium supplements

- No concurrent magnesium-containing antacids

- No concurrent thiazide-containing diuretics

- No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Intermediate endpoint biomarker modulation

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

George Wilding, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000068813

NCT ID:

NCT00022412

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • Prostatic Neoplasms

Name

Location

Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Meriter HospitalMadison, Wisconsin  53715