Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

NCT02343614 | Completed Phase 2 DMC

• 1 other identifier: 2401
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Muscle Invasive Bladder Cancer

Keywords

Intermediate risk; Cox-2 inhibitors

Outcome Measures

Primary Outcomes (2)

• Time to first recurrence

  5 years

• Safety assessed by description of grade 1-4 adverse events

  5 years

Study Arms (1)

ARM A

EXPERIMENTAL

Patients undergoing treatment with oral celecoxib

Drug: Celecoxib

Interventions

Celecoxib DRUG

ARM A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Related Publications (22)

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MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vincenzo VP Pagliarulo, Medical Doctor

  Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: March 1, 2003
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01