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Prostate CancerPhase 2NCT01220973

Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

A Phase 2 study testing atorvastatin calcium, celecoxib and laboratory biomarker analysis in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
atorvastatin calcium, celecoxib and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
4 sitesUnited States
Study dates
Feb 2009to 18 Nov 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Stage D0 disease
  • Tumor originally diagnosed as being limited to the prostate and now having a rising prostate-specific antigen (PSA) after definitive local therapy
  • Must have undergone local treatment via prostatectomy or radiotherapy
  • PSA values must be ≥ 0.2 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy
  • PSA values must be ≥ 2.0 ng/mL as determined by 2 measurements, ≥ 1 month apart and ≥ 6 months after radiotherapy
  • The first two PSA values along with a third value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
  • No metastatic disease by baseline bone scan and CT scan of the abdomen and/or pelvis

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • ECOG performance status 0-2
  • WBC ≥ 3,500/µL
  • ANC ≥ 1,500/µL
  • Platelet count > 100,000/µL
  • Hemoglobin > 10 g/dL
  • Serum creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min
  • Total bilirubin normal
  • SGOT and/or SGPT normal
  • No serious concomitant systemic disorder that, at the discretion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • No second primary malignancy within the past 5 years except adequately treated in situ carcinoma (e.g., non-melanomatous carcinoma of the skin) or other malignancy with no evidence of recurrence
  • No active clinically significant infection requiring antibiotics
  • No history of coronary artery disease
  • No myocardial infarction within the past 6 months
  • No sulfa allergy
  • No history of gastrointestinal bleeding

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormone-ablative treatment
  • Prior neoadjuvant hormone-ablative therapy allowed provided it was completed ≥ 3 months ago
  • More than 4 weeks since prior herbal products with hormonal activity such as soy, saw palmetto, or PC-SPES
  • No prior or concurrent nonsteroidal anti-inflammatory drug (NSAIDS) for 7 consecutive days
  • No COX-2 inhibitor and/or statin within the past 6 months
  • No concurrent warfarin or any other anticoagulant, calcitriol, fibric acid derivatives, lipid-modifying doses of niacin, or strong cytochrome P450 3A4 inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals) or inducers (e.g., St John wort)
  • No other concurrent anticancer agents or therapies including chemotherapy, hormonal therapy, radiotherapy, or experimental therapy

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Cooper Hospital

    Camden, New Jersey, 08103

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Robert Wood Johnson University Hospital at Hamilton

    Hamilton, New Jersey, 08690

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer.

Secondary

  • To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer.
  • To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).

OUTLINE: This is a multicenter study.

Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood sample collection at baseline and after completion of study therapy for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Conditions
Prostate Cancer
Being tested
atorvastatin calcium, celecoxib, laboratory biomarker analysis
Keywords
stage IV prostate cancer, stage III prostate cancer, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • atorvastatin calciumDrug

  • celecoxibDrug

  • laboratory biomarker analysisOther

Study groups in NCT01220973
Study groupRoleWhat they receive
Atorvastatin and CelecoxibExperimentalNot described
Receives: Drug: atorvastatin calcium; Drug: celecoxib; Other: laboratory biomarker analysis

What is being measured

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

  1. PSA Response

    PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.

    Measured: 6 months

Timeline

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

  1. First posted14 Oct 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completion18 Nov 2014
  4. Study completion18 Nov 2014

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220973
Sponsor's protocol ID
0220090006, 080811
Other IDs
0220090006, NCI-2012-00540
Status last verified
May 2018
First submitted
13 Oct 2010
Last updated
8 Jun 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing atorvastatin calcium, celecoxib and laboratory biomarker analysis in people with Prostate Cancer, run by Rutgers, The State University of New Jersey at 4 sites 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: finished, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 20 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PSA Response (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Jun 2018.

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