Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI, Other	CDR0000341468 UNC-LCCC-0109, UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109, NCT00073970

Trial Description

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 Contact Information

Trial Lead Organizations/Sponsors

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Raj S. Pruthi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00073970
Information obtained from ClinicalTrials.gov on September 16, 2009

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