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AzTrials

Prostate CancerPhase 2NCT00073970

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

A Phase 2 study testing celecoxib in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
celecoxib
How many people
37 participants
Where
1 siteUnited States
Study dates
Apr 2003to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599-7235

Other trials in United States

About this study

Official title: A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
celecoxib
Keywords
recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • celecoxibDrug

    Also called Celebrex

    400mg, given twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Secondary outcomes (1)

  1. 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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionJun 2005
  4. Study completionJan 2006

Why it stopped: Study stopped due to increased cardiovascular risks associated with Celebrex

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00073970
Sponsor's protocol ID
LCCC 0109
Other IDs
UNC-01-SURG-655-ORC, CDR0000341468
Status last verified
May 2012
First submitted
10 Dec 2003
Last updated
23 May 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib in people with Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped due to increased cardiovascular risks associated with Celebrex). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of COX-2 inhibitors on PSA level (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00073970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.

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