Celecoxib in Treating Patients With Bladder Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00006124

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer.

PURPOSE: This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer.

Condition	Intervention	Phase
Bladder Cancer	Drug: Celecoxib Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Phase IIb/III Chemoprevention Trial of Celecoxib to Prevent Recurrence of Superficial Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Time to Recurrence [ Time Frame: Follow-up every 12 weeks until recurrence or disease progression, or end of study up to 104 weeks ] [ Designated as safety issue: No ]
Time from enrollment to development of histologically confirmed transitional cell carcinoma (TCC) of the bladder while on study considered "recurrence".

Enrollment:	44
Study Start Date:	July 2000
Study Completion Date:	April 2008
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo orally twice a day for 54 to 102 weeks	Drug: Placebo Placebo orally twice a day for minimum of 54 ± 2 weeks and a maximum of 102 ± 2 weeks.
Active Comparator: Celecoxib 200 mg orally twice a day for 54 to 102 weeks	Drug: Celecoxib 200 mg orally twice a day for minimum of 54 ± 2 weeks and a maximum of 102 ± 2 weeks. Other Name: Celebrex

Detailed Description:

OBJECTIVES:

Compare the time to recurrence after treatment with celecoxib vs placebo in patients with superficial transitional cell carcinoma of the bladder at high risk for recurrence.
Correlate the modulation of one or more biomarkers with recurrence of bladder cancer and confirm the value of the marker(s) as a surrogate endpoint biomarker for bladder cancer and celecoxib.
Determine the toxicity of celecoxib in these patients.
Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to center and presence of Tis disease (yes vs no). Patients are randomized to one of two arms.

Arm I: Patients receive oral celecoxib twice daily.
Arm II: Patients receive oral placebo twice daily. Treatment continues in both arms for 1-2 years in the absence of unacceptable toxicity, development of recurrent or invasive bladder carcinoma, or development of a second malignancy requiring radiotherapy or systemic therapy.

Quality of life is assessed at baseline and at week 54.

Patients are followed at 6 weeks and then every 12 weeks until the last randomized patient has been on the study for 1 year or until disease recurrence.

PROJECTED ACCRUAL: A total of 152 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

³18 yrs.old with histologically documented transitional cell carcinoma (TCC)of the bladder: Ta (G3,multifocal or ³2 tumors w/in 12 months), and/or T1 and/or Tis.
Transurethral resection of bladder tumour (TURBT) within 9 months of randomization.
6 weekly doses of induction Bacille Calmette-Guérin (BCG) and 3 doses of maintenance BCG.
NED (without evidence of disease) by cystoscopy and cytology at the post-induction cystoscopy.
Negative Intravenous Pyelogram (IVP) or other upper tract imaging study within 9 months prior to randomization.
Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (PS) = 0 - 2.
Adequate bone marrow, hepatic, and renal function within 4 weeks of randomization.

Exclusion Criteria:

TCC involves the prostatic urethra or upper urinary tract
Use of aspirin (> 100 mg/day) or other Nonsteroidal Antiinflammatory Drugs (NSAIDs) 14 days prior to randomization.
Oral or IV corticosteroids for> 2 weeks or inhaled corticosteroids for > 4 weeks 6 months prior to randomization.
Active Gastrointestinal (GI) disease, renal, hepatic, or bleeding disorder.
Adverse reactions to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs.
Use of lithium or fluconazole.
Specific cardiovascular disease history.
Increased cardiovascular risk must be controlled by cardiologist, internist, or primary care physician.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006124

Locations

United States, Texas
Baylor College of Medicine Comprehensive Cancer Center
Houston, Texas, United States, 77030
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Anita L. Sabichi, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

UT MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Anita Sabichi, M.D., UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00006124 History of Changes
Other Study ID Numbers:	ID99-368, P50CA083639, P30CA016672, MDA-ID-99368, NCI-P00-0165, SC-NQ4-99-02-006, CDR0000068139
Study First Received:	August 3, 2000
Last Updated:	May 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

recurrent bladder cancer
Celecoxib
Superficial Bladder Cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012