Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy - Full Text View

Sponsor:	UNC Lineberger Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00073970

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: celecoxib	Phase II

Study Type:	Interventional
Study Design:	Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Study Start Date:	April 2003
Study Completion Date:	January 2006
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

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

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073970

Locations

United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7235

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Raj S. Pruthi, MD

UNC Lineberger Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00073970 History of Changes
Other Study ID Numbers:	LCCC 0109, UNC-01-SURG-655-ORC, PFIZER-UNC-LCCC-0109, CDR0000341468
Study First Received:	December 10, 2003
Last Updated:	September 16, 2011
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:

recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012