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.
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
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 group | Role | What they receive |
|---|---|---|
| Atorvastatin and Celecoxib | Experimental | Not 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.
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.
- First posted14 Oct 2010 (estimated)
- Study startFeb 2009
- Primary completion18 Nov 2014
- Study completion18 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan Goodin, PharmD, Rutgers, The State University of New Jersey
- Investigators
- Susan Goodin, PhD, FCCP, BCOP, Principal investigator, Rutgers Cancer Institute of New Jersey
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01220973
- Acronym / sponsor ID
- 0220090006, 080811
- Conditions
- Prostate Cancer
- Keywords
- stage IV prostate cancer, stage III prostate cancer, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- 18 Nov 2014 (actual)
- Study completion
- 18 Nov 2014 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Posted 20 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin and Celecoxib | Experimental | Drug: atorvastatin calcium, Drug: celecoxib, Other: laboratory biomarker analysis |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatin calcium | Drug | Atorvastatin and Celecoxib |
| celecoxib | Drug | Atorvastatin and Celecoxib |
| laboratory biomarker analysis | Other | Atorvastatin and Celecoxib |
Primary outcome
PSA Response
Time frame: 6 months
PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Goodin, PhD, FCCP, BCOP principal investigator
Rutgers Cancer Institute of New Jersey
4 sites in 1 country: see every site and its status.
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.