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Clinical Trial Name - Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate C
| Original Study ID : CDR0000068812 |
| Secondary ID : Array |
| NCT ID : NCT00022399 |
| Brief Title : Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer |
| Official Title : A Randomized, Placebo-Controlled Trial Of Celecoxib In Men Pre-Prostatectomy For Clinically Localized Adenocarcinoma Of The Prostate: Evaluation Of Drug-Specific Biomarker Modulation |
| Brief 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. |
| Source : National Cancer Institute (NCI) |
| Detailed 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. |
| Overall Status : Completed |
| Start Date : September 2001 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Prevention, Randomized, Double-Blind, Active Control |
| Verification Date : October 2004 |
| First Received Date : August 10, 2001 |
| Trial 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 |
| Gender : Male |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21231-2410 |
| Country : United States |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Type : Procedure |
| Name : conventional surgery |
| Type : Procedure |
| Name : neoadjuvant therapy |
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