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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00022399
First Posted: January 27, 2003
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: celecoxib Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022399


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Michael A. Carducci, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00022399     History of Changes
Other Study ID Numbers: CDR0000068812
JHOC-J0007
JHOC-00030801
NCI-N01-95129
NCI-P01-0186
First Submitted: August 10, 2001
First Posted: January 27, 2003
Last Update Posted: February 21, 2011
Last Verified: October 2004

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents