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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.
First Received: December 10, 2003   Last Updated: July 23, 2008   History of Changes
Sponsor: UNC Lineberger Comprehensive Cancer Center
Collaborator: 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

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

Resource links provided by NLM:


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

Additional Information:
No publications provided

Study ID Numbers: CDR0000341468, UNC-LCCC-0109, UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109
Study First Received: December 10, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00073970     History of Changes
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

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

ClinicalTrials.gov processed this record on November 27, 2009