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Home > "C" Clinical Trials Conditions > Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer  Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
For Condition: stage 1 prostate cancer,adenocarcinoma of the prostate,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCarducci, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Michael Carducci 410-614-3977
Additional Information:
Study ID Numbers: CDR0000068812; NCI-P01-0186,JHOC-00030801,NCI-N01-95129,JHOC-J0007
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022399
Other Stage 2 Prostate Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
2. TG4010 in Treating Patients With Prostate Cancer
3. Chemotherapy and Hormone Therapy in Treating Patients With Prostate Cancer
4. Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
5. Diet and PSA Levels in Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
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