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

NCT ID: NCT00022399

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-25
• Study Completion Date: 2005-01-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Celecoxib

Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Placebo-control

Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Interventions

celecoxib

400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Intervention Type: DRUG

Placebos

Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Intervention Type: DRUG

Other Intervention Names

celebrex

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A. Carducci, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Antonarakis ES, Heath EI, Walczak JR, Nelson WG, Fedor H, De Marzo AM, Zahurak ML, Piantadosi S, Dannenberg AJ, Gurganus RT, Baker SD, Parnes HL, DeWeese TL, Partin AW, Carducci MA. Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers. J Clin Oncol. 2009 Oct 20;27(30):4986-93. doi: 10.1200/JCO.2009.21.9410. Epub 2009 Aug 31.

Reference Type: RESULT

PMID: 19720908 (View on PubMed)

Other Identifiers

P50CA058236

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068812

Identifier Type: -

Identifier Source: secondary_id

00-03-08-01

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-N01-95129

Identifier Type: -

Identifier Source: secondary_id

NCI-P01-0186

Identifier Type: -

Identifier Source: secondary_id

J0007

Identifier Type: -

Identifier Source: org_study_id