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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00022399
• Date of registration: 10/08/2001
• Primary sponsor: Sidney Kimmel Comprehensive Cancer Center
• Public title: Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
• Scientific 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
• Date of first enrolment: September 2001
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00022399
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Michael A. Carducci, MD
• Affiliation: Sidney Kimmel Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: celecoxib

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Secondary ID(s)

CDR0000068812

JHOC-00030801

JHOC-J0007

NCI-N01-95129

NCI-P01-0186

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)