Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Not specified | NCI, Other | LCCC 0109 UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109, CDR0000341468, UNC-LCCC-0109, NCT00073970 |
Summary
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.
Further Study Information
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 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
Trial Lead Organizations/Sponsors
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
National Cancer Institute| Raj S. Pruthi |  | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00073970
Information obtained from ClinicalTrials.gov on December 14, 2011
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