Status:
TERMINATED
Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 prosta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00073970
Start Date
April 1 2003
End Date
January 1 2006
Last Update
May 23 2012
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7235