Bladder Cancer Study.

Phase 2

Completed

• Conditions: Health Condition 1: C679- Malignant neoplasm of bladder, unspecified

• Registration Number: CTRI/2007/091/000034
• Lead Sponsor: Cadila Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 122

Inclusion Criteria

1.INFORMED CONSENT OBTAINED & SIGNED:

Ability to understand and the willingness to sign a written informed consent document.

2.DISEASE CHARACTERISTICS:

Patients with newly diagnosed superficial transitinal cell carcinoma with compltetely resected papilary tumors and high probability of recurrence risk i.e. stage T1 Gr.2, T1 Gr3 & CIS AND Ta or T1 grade with an increased risk of recurrence defined as 2 tumors (primary and recurrent or 2 recurrences) with-in 1 year, 3 or more recurrences with in the last 6 months and/or carcinoma in situ on atleast one random biopsy.

3. PATIENT CHARACTERISTICS:

Age:18 completed years and above

Performance status:ECOG 0-2

Life expectancy:At least 24 weeks

Hematopoietic:Absolute neutrophil count greter then or equal to 1,500/mm3

Platelet count greter then or equal to 100,000/mm3

Hemoglobin greter then or equal to 9.0 g/dL

Re- Cystoscopy:No evidence of residual tumor in the cystoscopy done 6 weeks after the TUR.

Exclusion Criteria

• Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study.

• No patient who has eczema should be allowed to participate in this study.

• Patients who are immuno-compromised should not be enrolled.

• Patients with severe hepatic dysfunctions or evidence of Cirrhosis should not be enrolled.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition

to agents used in the study.

• Pregnant women or nursing women are excluded from this study because agents used in the study

have potential for teratogenic or abortifacient effects. Because there is known potential risk for

adverse events in nursing infants secondary to treatment of the mother with investigational agent,

breastfeeding should be discontinued if the mother is treated with investigational product.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,

symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythemia, or psychiatric

illness/social situations that would limit compliance with study requirements.

• Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent

• Previous splenectomy

• Clinically significant active infection

• Patients with uncontrolled diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified