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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.

Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00073970
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: celecoxib
 Phase II

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 2003

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073970

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill    
      Chapel Hill, North Carolina, United States, 27599-7235

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Raj S. Pruthi, MD     UNC Lineberger Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000341468, UNC-LCCC-0109, UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109
First Received:   December 10, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00073970
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer  
stage I prostate cancer  
stage II prostate cancer  
adenocarcinoma of the prostate  

Study placed in the following topic categories:
Celecoxib
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 19, 2008

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