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Alkylating Agent

Celecoxib + Chemotherapy for Bladder Cancer (BLAST Trial)

Phase 1
Waitlist Available
Led By Aihua Edward Yen, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have tumor tissues from transurethral resection of the bladder tumor (TURBT) that is within 120 days of registration and available for submission. Tissue sample must be sufficient for IHC testing; that is,it must be sufficient tumor tissues for correlative science after pathologic diagnosis [i.e., enough tumor tissue to pass the staging criteria in 4c].
Patients must have a Zubrod performance status of 0, 1 or 2.
Must not have
Patients must not have peripheral neuropathy ≥ Grade 2.
Patients must not have presence of Class III or IV heart failure, according to New York Heart Association Classifications, or a known left ventricular ejection fraction of less than 50%. Note: LVEF evaluation by echocardiogram or multi-gated acquisition scan (MUGA) is not required prior to registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through treatment completion, up to 154 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial will compare gene expression in tumor tissue of patients before and after treatment with chemotherapy plus celecoxib, to see if celecoxib has any effect on tumor cells.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include those common to chemotherapy like nausea, fatigue, hair loss; plus risks from Celecoxib such as stomach upset, kidney problems, increased risk of heart attack/stroke. Cisplatin may cause nerve damage and hearing changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent bladder tumor tissue sample from surgery ready for testing.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My tumor is invasive, measures at least 10mm, or causes kidney swelling.
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I've had the required scans and tests for cancer staging within the last 56 days.
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I am 18 years old or older.
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My bladder cancer diagnosis includes urothelial carcinoma, possibly with other types but not purely small cell, adenocarcinoma, or squamous cell.
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My liver is functioning well according to recent tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe numbness or pain in my hands or feet.
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My heart functions well and I do not have severe heart failure.
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I am not allergic to cisplatin, gemcitabine, or celecoxib.
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I haven't had a stroke, heart attack, or severe angina in the last 6 months.
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I have not had chemotherapy for bladder cancer.
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I have been on stable blood thinners since my clot or lung blockage in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through treatment completion, up to 154 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through treatment completion, up to 154 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Changes Cytokeratin 14 and phospho-histone H3 (proliferation markers)
Changes in COX2 IHC staining
Changes in gene expression signatures in association with therapeutic response

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Celecoxib plus Gemcitabine/Cisplatin chemoExperimental Treatment3 Interventions
Celecoxib plus Gemcitabine/Cisplatin neoadjuvant chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Celecoxib
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,147 Total Patients Enrolled
Aihua Edward Yen, MD5.01 ReviewsPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine

Media Library

Cisplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02885974 — Phase 1
Bladder Cancer Research Study Groups: Celecoxib plus Gemcitabine/Cisplatin chemo
Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02885974 — Phase 1
Cisplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02885974 — Phase 1
~2 spots leftby Dec 2025
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