Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

• Status: Completed
• Trial end date: 2005-01-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

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