Clinical trial NCT01220973: Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
Official title: Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers Cancer Institute of New Jersey
name: National Cancer Institute (NCI)
First posted: 2010-10-14
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PSA Response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Camden
country: United States
facility: Cooper Hospital
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson University Hospital at Hamilton
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Susan Goodin, PhD, FCCP, BCOP
role: PRINCIPAL_INVESTIGATOR
References: