Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy

• Status: Terminated
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

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