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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy  Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
For Condition: adenocarcinoma of the prostate,stage 1 prostate cancer,recurrent prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): UNC Lineberger Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 relapsedprostate cancer following radiation therapy or radical prostatectomy.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RajPruthi, Study Chair, UNC Lineberger Comprehensive Cancer Center
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7235
United States
Recruiting Raj Pruthi 919-966-2754
Additional Information:
Study ID Numbers: CDR0000341468; UNC-01-SURG-655-ORC,UNC-LCCC-0109,PFIZER-UNC-LCCC-0109
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073970
Other Adenocarcinoma Of The Prostate Studies:
1. Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
2. Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer
3. Hormone Therapy in Treating Men With Stage IV Prostate Cancer
4. Genistein in Treating Patients With Stage II, Stage III, or Stage IV Prostate Cancer
5. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
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