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| ID | Type | Description | Link |
|---|---|---|---|
| 0220090006 | Other Identifier | IRB number | |
| NCI-2012-00540 | Other Identifier | CTRP (Clinical Trails Reporting Program) |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin and Celecoxib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin calcium | Drug |
| ||
| celecoxib |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response | PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time. | 6 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Stage D0 disease
Must have undergone local treatment via prostatectomy or radiotherapy
No metastatic disease by baseline bone scan and CT scan of the abdomen and/or pelvis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior hormone-ablative treatment
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
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| Name | Affiliation | Role |
|---|---|---|
| Susan Goodin, PhD, FCCP, BCOP | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States | ||
| Cooper Hospital |
We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.
Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 02/25/2009 and closed to accrual on 11/13/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin and Celecoxib | atorvastatin calcium celecoxib laboratory biomarker analysis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| laboratory biomarker analysis | Other |
|
| Camden |
| New Jersey |
| 08103 |
| United States |
| Robert Wood Johnson University Hospital at Hamilton | Hamilton | New Jersey | 08690 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin and Celecoxib | atorvastatin calcium celecoxib laboratory biomarker analysis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | PSA Response | PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time. | A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy. | Posted | Count of Participants | Participants | 6 months |
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Adverse events were collected over a period of 900 days per patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin and Celecoxib | atorvastatin calcium celecoxib laboratory biomarker analysis | 0 | 27 | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Goodin PharmD, FCCP, BCOP | Rutgers Cancer Institute of New Jersey | 732-235-6783 | goodin@cinj.rutgers.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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