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

Prostate Cancer Clinical Trial

Official title:

A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00073970
• Other study ID #: LCCC 0109
• Secondary ID: UNC-01-SURG-655-
• Status: Terminated
• Phase: Phase 2
• First received: December 10, 2003
• Last updated: May 21, 2012
• Start date: April 2003
• Est. completion date: January 2006

Study information

• Verified date: May 2012
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: January 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• celecoxib
400mg, given twice daily

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of COX-2 inhibitors on PSA level	To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.	9 months	No
Secondary	Disease progression rate	Progression will be defined as evidence of biochemical relapse (increase in serum PSA levels on 3 successive determinations, provided that the increase is at least 5 ng/ml from baseline) or clinical objective progression or relapse - i.e. the development of new lesions by digital rectal exam (DRE) or enlargement of existing lesion, or the development of symptoms of clinical progression (specifically bony pain) which is confirmed by radiological imaging studies	5 years	No