Trial Summary
What is the purpose of this trial?The purpose of this study is to compare patient tumor tissue before and after treatment with chemotherapy plus celecoxib. Investigators will look at gene expression, to see what effect celecoxib may have on tumor cells.
Eligibility Criteria
This trial is for adults with localized, muscle-invasive bladder cancer who haven't had systemic chemotherapy. They need recent scans and tests showing good organ function, no severe neuropathy or uncontrolled illnesses, not pregnant/nursing, and can't be regularly using NSAIDs or have a history of significant bleeding or heart issues.Inclusion Criteria
I can take care of myself and am up and about more than 50% of my waking hours.
Your blood tests must show: i. a certain amount of white blood cells, ii. a certain level of hemoglobin, and iii. a certain number of platelets.
My tumor is invasive, measures at least 10mm, or causes kidney swelling.
+9 more
Exclusion Criteria
I haven't had serious bleeding issues in the last 6 months.
You cannot have asthma that is sensitive to aspirin.
I haven't had a stroke, heart attack, or severe angina in the last 6 months.
+9 more
Participant Groups
The study is testing the effects of adding Celecoxib to standard chemotherapy (Cisplatin and Gemcitabine) on bladder cancer tissue. Researchers will compare gene expression in tumor samples taken before and after treatment to see how Celecoxib affects the cells.
1Treatment groups
Experimental Treatment
Group I: Celecoxib plus Gemcitabine/Cisplatin chemoExperimental Treatment3 Interventions
Celecoxib plus Gemcitabine/Cisplatin neoadjuvant chemotherapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
πΊπΈ Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
π¨π¦ Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
π―π΅ Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baylor ClinicHouston, TX
Harris Health System - Smith ClinicHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor