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Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02343614
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale

Brief Summary:

The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.

Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.


Condition or disease Intervention/treatment Phase
Non Muscle Invasive Bladder Cancer Drug: Celecoxib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
Study Start Date : March 2003
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: ARM A
Patients undergoing treatment with oral celecoxib
Drug: Celecoxib



Primary Outcome Measures :
  1. Time to first recurrence [ Time Frame: 5 years ]
  2. Safety assessed by description of grade 1-4 adverse events [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven urothelial bladder cancer
  • Intermediate risk NMIBC
  • ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
  • Imaging study excluding upper urinary tract TCC

Exclusion Criteria:

  • Pregnant and lactating women;
  • Advanced co-existing medical or psychiatric disorders;
  • Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
  • History of allergy to sulfonamide drugs;
  • Concomitant investigational medications.

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): NCT02343614


Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Consorziale
Investigators
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Principal Investigator: Vincenzo VP Pagliarulo, Medical Doctor Azienda Ospedaliero-Universitaria Consorziale

Publications:

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Responsible Party: Pagliarulo Vincenzo, Medical Doctor, Azienda Ospedaliero-Universitaria Consorziale
ClinicalTrials.gov Identifier: NCT02343614     History of Changes
Other Study ID Numbers: 2401
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by Pagliarulo Vincenzo, Azienda Ospedaliero-Universitaria Consorziale:
Intermediate risk
Cox-2 inhibitors
Additional relevant MeSH terms:
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Celecoxib
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action