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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00073970

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

33.1

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: celecoxib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Effect of COX-2 inhibitors on PSA level [9 months]
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.

Secondary Outcome Measures

Disease progression rate [5 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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