Expired Study
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Chapel Hill, North Carolina 27599


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.


Study summary:

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.


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


NCT ID:

NCT00073970


Primary Contact:

Study Chair
Raj S. Pruthi, MD
UNC Lineberger Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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