Clinical trial NCT00073970: Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
Official title: A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-12-11
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect of COX-2 inhibitors on PSA level
timeFrame: 9 months
Secondary outcomes:
measure: Disease progression rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Raj S. Pruthi, MD
role: STUDY_CHAIR
References: