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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 Recurrent Prostate Cancer Studies:
1. Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

2. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

3. Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

4. Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer

5. Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer

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