Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003832
First received: November 1, 1999
Last updated: January 24, 2013
Last verified: January 2013

November 1, 1999
January 24, 2013
July 1999
June 2002   (final data collection date for primary outcome measure)
Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00003832 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment

OBJECTIVES:

I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.

II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.

OUTLINE:

Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Drug: bromodeoxyuridine
    Given IV
    Other Names:
    • 5-BrdU
    • 5-bromodeoxyuridine
    • BrdU
    • broxuridine
  • Procedure: conventional surgery
    Undergo surgery
    Other Name: surgery, conventional
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (bromodeoxyuridine)
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
Interventions:
  • Drug: bromodeoxyuridine
  • Procedure: conventional surgery
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Not Provided
June 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of stage I or II (T1-2) carcinoma of the prostate

    • PSA greater than 8 ng/mL
    • Abnormal findings on digital rectal examination
  • Eligible for radical prostatectomy
  • Performance status - ECOG 0 or 1
  • No prior biologic therapy
  • No prior chemotherapy
  • No prior neoadjuvant hormonal therapy
  • No prior radiotherapy
  • See Disease Characteristics
  • No prior therapy that would affect tumor growth rates or volume
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003832
NCI-2012-02297, 98-374, CDR0000066989
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Leonard Glode University of Colorado, Denver
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP