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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: celecoxib

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00073970

CDR0000341468 (Other Identifier)

LCCC 0109

UNC-01-SURG-655-ORC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)