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Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy

This study has been terminated.
(Study stopped due to increased cardiovascular risks associated with Celebrex)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00073970
First received: December 10, 2003
Last updated: May 21, 2012
Last verified: May 2012

December 10, 2003
May 21, 2012
April 2003
June 2005   (final data collection date for primary outcome measure)
Effect of COX-2 inhibitors on PSA level [ Time Frame: 9 months ] [ Designated as safety issue: No ]
To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.
Not Provided
Complete list of historical versions of study NCT00073970 on ClinicalTrials.gov Archive Site
Disease progression rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Progression will be defined as evidence of biochemical relapse (increase in serum PSA levels on 3 successive determinations, provided that the increase is at least 5 ng/ml from baseline) or clinical objective progression or relapse - i.e. the development of new lesions by digital rectal exam (DRE) or enlargement of existing lesion, or the development of symptoms of clinical progression (specifically bony pain) which is confirmed by radiological imaging studies
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: celecoxib
400mg, given twice daily
Other Name: Celebrex
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
January 2006
June 2005   (final data collection date for primary outcome measure)

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
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073970
LCCC 0109, UNC-01-SURG-655-ORC, CDR0000341468
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Raj S. Pruthi, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
May 2012

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