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| 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 |
| Study Start Date: | April 2003 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Diagnosis of clinically localized adenocarcinoma of the prostate
Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 6 months since prior adjuvant or neoadjuvant hormonal therapy
Radiotherapy
Surgery
Contacts and Locations| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7235 | |
| Study Chair: | Raj S. Pruthi, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| 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 |
|
recurrent prostate cancer stage I prostate cancer stage II prostate cancer adenocarcinoma of the prostate |
|
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 |