Prostate Cancer Clinical Trial
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Summary
RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer.
PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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