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Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
This study is ongoing, but not recruiting participants.
Study NCT00073970   Information provided by National Cancer Institute (NCI)
First Received: December 10, 2003   Last Updated: July 23, 2008   History of Changes

December 10, 2003
July 23, 2008
April 2003
 
 
 
Complete list of historical versions of study NCT00073970 on ClinicalTrials.gov Archive Site
 
 
 
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer

RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.

OBJECTIVES:

  • Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy.
  • Compare the PSA doubling times in patients treated with this drug vs historical controls.
  • Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values.
  • Determine the time to clinical recurrence in patients treated with this drug.

OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the absence of disease progression. Patients may continue treatment beyond 5 years at the discretion of the treating physician.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
Prostate Cancer
Drug: celecoxib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of clinically localized adenocarcinoma of the prostate

    • T1 or T2 disease
  • Received prior primary treatment with definitive radiotherapy (at least 5,500 cGy) OR radical prostatectomy
  • Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following:

    • Detectable and rising prostate-specific antigen (PSA) after surgery (at least 2 values above the residual cancer detection limit of the assay)
    • PSA at least 2 values above 1 ng/mL OR at least 3 rising values at any level after radiotherapy
  • PSA no greater than 10 ng/mL

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • ALT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine normal

Other

  • No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs
  • No untreated peptic ulcer disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • More than 6 months since prior adjuvant or neoadjuvant hormonal therapy

    • Duration of prior adjuvant or neoadjuvant hormonal therapy must have been no more than 6 months

Radiotherapy

  • See Disease Characteristics
  • Prior salvage radiotherapy after prostatectomy allowed

Surgery

  • See Disease Characteristics
Male
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073970
 
CDR0000341468, UNC-LCCC-0109, UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Raj S. Pruthi, MD UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
June 2005

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