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A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation


OBJECTIVES:

- Compare biomarker modulation (prostaglandin levels) in tissue samples of patients with
localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by
prostatectomy.

- Compare the effect of these regimens on angiogenic factors within the prostate in these
patients.

- Determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these
patients.

- Compare the toxicity profiles of these regimens in these patients.

- Compare the compliance of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral neoadjuvant celecoxib twice daily.

- Arm II: Patients receive oral neoadjuvant placebo twice daily. Treatment in both arms
continues for at least 4 weeks followed by prostatectomy.

Patients are followed within 1 month and then at 3 months.

PROJECTED ACCRUAL: A total of 60-70 patients (at least 30 per arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed localized adenocarcinoma of the prostate
with one or more of the following:

- Gleason sum at least 7

- Prostate-specific antigen (PSA) at least 15 ng/mL

- Clinical stage T2b or T2c (stage II)

- Any combination of PSA, clinical stage, or Gleason sum with an estimated risk of
capsular penetration greater than 45%

- At least 3 positive core biopsies

- Planned radical prostatectomy

- No metastatic disease secondary to prostate cancer

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 9 g/dL

- No history of bleeding disorders

Hepatic:

- Bilirubin less than 1.5 mg/dL

- AST/ALT less than 1.5 times upper limit of normal

- No viral hepatitis

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

Other:

- No history of hypersensitivity and/or adverse reactions to salicylates

- No allergy to sulfa-containing medications

- No other active malignancy within the past 5 years except superficial bladder cancer
or nonmelanoma skin cancer

- No medical or psychiatric problem that would preclude study participation

- No active infection

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunologic therapy for prostate cancer

Chemotherapy:

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- No prior androgen ablation for prostate cancer

- At least 4 weeks since prior hormonal therapy and recovered

- At least 30 days since prior chronic use (more than 3 times per week for more than 2
weeks) of glucocorticoids

- No concurrent glucocorticoids

Radiotherapy:

- At least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and
recovered

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior major surgery and recovered

Other:

- No prior investigational therapy for prostate cancer

- No prior or concurrent chronic anticoagulants

- No prior cyclo-oxygenase-2 inhibitor therapy (e.g., rofecoxib or celecoxib)

- At least 4 weeks since prior initiation of vitamins (except multivitamin) or herbs
with known effects on prostate function (PSA)

- At least 30 days since prior chronic use (more than 3 times per week for more than 2
weeks) of aspirin (greater than 100 mg/day) or non-steroidal anti-inflammatory drugs
(NSAIDs)

- At least 24 hours since prior use and no concurrent use of any of the following:

- Over-the-counter (OTC) or prescription products containing aspirin or NSAIDs;
OTC products containing bismuth subsalicylate, sodium salicylate, and/or
magnesium salicylate; choline salicylate; ranitidine; cimetidine; famotidine; or
lansoprazole

- No aspirin (100 mg/day) within 1 week prior to surgery

- No concurrent addition of vitamins or herbal supplements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Michael A. Carducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068812

NCT ID:

NCT00022399

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410