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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response

Outcome Time Frame:

up to 2.5 years (6 months therapy and 2 years of follow-up)

Safety Issue:


Principal Investigator

Susan Goodin, PharmD, FCCP, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • stage III prostate cancer
  • recurrent prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Karmanos Cancer Center Detroit, Michigan  48201
Robert Wood Johnson University Hospital at Hamilton Hamilton, New Jersey  
Cooper Hospital Camden, New Jersey  08103