NCT00073970

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

December 10, 2003

Last Update Submit

May 21, 2012

Conditions

Prostate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage II prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (1)

  • Disease progression rate

    5 years

Interventions

celecoxibDRUG

400mg, given twice daily

Also known as: Celebrex

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Chapel Hill, North Carolina, 27599-7235, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Raj S. Pruthi, MD

    UNC Lineberger Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

April 1, 2003

Primary Completion

June 1, 2005

Study Completion

January 1, 2006

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

US(1)