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

Original Study ID : CDR0000341468

Secondary ID : Array

NCT ID : NCT00073970

Brief Title : 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

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.

Source : National Cancer Institute (NCI)

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.

Overall Status : Active, not recruiting

Start Date : April 2003

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Open Label

Verification Date : June 2005

First Received Date : December 10, 2003

Trial 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

Gender : Male

Minimum Age : N/A

Maximum Age : N/A

Healthy Volunteers : No

Facilities

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

City : Chapel Hill

State : North Carolina

Zip Code : 27599-7235

Country : United States

Interventions

Type : Drug

Name : celecoxib

Clinical Trial Name - Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radica