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Phase II Study of Celecoxib in Patients With Prostate Cancer in Biochemical Relapse After Prior Definitive Radiotherapy or Radical Prostatectomy
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
Basic Trial Information
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Phase II
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Closed
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Not specified
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NCI, Pharmaceutical / Industry
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UNC-LCCC-0109
UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109, NCT00073970
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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.
Entry Criteria Disease Characteristics:
- Diagnosis of clinically localized adenocarcinoma of the prostate
- 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
Prior/Concurrent Therapy:
Biologic therapy 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
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Prior salvage radiotherapy after prostatectomy allowed
Surgery - See Disease Characteristics
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - ALT no greater than 2.5 times upper limit of normal
Renal Other - No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory drugs, or sulfa drugs
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No untreated peptic ulcer disease
Expected Enrollment A total of 100 patients will be accrued for this study. 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.
Trial Contact Information
Trial Lead Organizations Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | | | | Raj Pruthi, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer | | | Trial Start Date | | 2003-04-03 | | | Registered in ClinicalTrials.gov | | NCT00073970 | | | Date Submitted to PDQ | | 2003-10-17 | | | Information Last Verified | | 2005-06-09 | | | NCI Grant/Contract Number | | P30-CA16520 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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