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

NCT ID: NCT00073970

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2006-01-31

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 of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.

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 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

celecoxib

400mg, given twice daily

Intervention Type: DRUG

Other Intervention Names

Celebrex

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj S. Pruthi, MD

Role: STUDY_CHAIR

UNC Lineberger Comprehensive Cancer Center

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

UNC-01-SURG-655-ORC

Identifier Type: -

Identifier Source: secondary_id

CDR0000341468

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 0109

Identifier Type: -

Identifier Source: org_study_id