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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Placebos
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celecoxib

Placebo-control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
February 6, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022399
Brief Title
Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2002 (undefined)
Primary Completion Date
January 31, 2005 (Actual)
Study Completion Date
January 31, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.
Arm Title
Placebo-control
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
celebrex
Intervention Description
400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Carducci, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19720908
Citation
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.
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Celecoxib Compared With No Treatment Before Surgery in Treating Patients With Localized Prostate Cancer

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