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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 See Disease Characteristics Prior salvage radiotherapy after prostatectomy allowed Surgery See Disease Characteristics

Sites / Locations

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Outcomes

Primary Outcome Measures

Effect of COX-2 inhibitors on PSA level
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
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

Full Information

First Posted
December 10, 2003
Last Updated
May 21, 2012
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to increased cardiovascular risks associated with Celebrex
Study Start Date
April 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
400mg, given twice daily
Primary Outcome Measure Information:
Title
Effect of COX-2 inhibitors on PSA level
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Disease progression rate
Description
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
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj S. Pruthi, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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