15 Participants Needed

Celecoxib + Chemotherapy for Bladder Cancer

(BLAST Trial)

Recruiting at 1 trial location
AE
Overseen ByAihua Edward Yen, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Baylor College of Medicine
Must be taking: Gemcitabine, Cisplatin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop regular use of NSAIDs (non-steroidal anti-inflammatory drugs) more than twice a week and aspirin more than 325 mg at least three times a week. Low-dose aspirin up to 100 mg per day is allowed, and no washout period is needed if you stop the higher doses.

Is the combination of Celecoxib and chemotherapy safe for treating bladder cancer?

Cisplatin, a chemotherapy drug often used in bladder cancer treatment, can cause side effects like nausea, vomiting, and kidney problems. In some studies, severe blood-related side effects and kidney failure were noted, especially in patients with existing kidney issues. Gemcitabine, another chemotherapy drug, is generally considered safe but can also cause side effects like low blood counts and fatigue.12345

What makes the drug combination of Celecoxib, Cisplatin, and Gemcitabine unique for treating bladder cancer?

This drug combination is unique because it includes Celecoxib, a COX-2 inhibitor, which may enhance the effects of chemotherapy drugs like Cisplatin and Gemcitabine by inhibiting tumor growth and reducing recurrence, offering a novel approach compared to standard treatments that typically rely on direct chemotherapy or immunotherapy alone.678910

What data supports the effectiveness of the drug combination Celecoxib, Cisplatin, and Gemcitabine for bladder cancer?

Research shows that the combination of Gemcitabine and Cisplatin is effective and less toxic than other regimens for advanced bladder cancer. Cisplatin-based chemotherapy is a standard treatment for muscle-invasive bladder cancer, improving survival rates.511121314

Who Is on the Research Team?

AE

Aihua Edward Yen, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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.
See 8 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.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant chemotherapy with Celecoxib, Gemcitabine, and Cisplatin

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Celecoxib
  • Cisplatin
  • Gemcitabine
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Celecoxib plus Gemcitabine/Cisplatin chemoExperimental Treatment3 Interventions

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Platinol for:
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Approved in United States as Platinol for:
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Approved in Canada as Platinol for:
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Approved in Japan as Platinol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Published Research Related to This Trial

Bladder cancer, often linked to environmental and lifestyle factors, shows promising outcomes with early intervention; 87% of early-stage patients can achieve 10-year survival after appropriate treatment, although many still require radical cystectomy.
Recent studies suggest that the gemcitabine and cisplatin regimen is as effective as traditional chemotherapy with less toxicity, making it the new standard for advanced bladder cancer treatment in ongoing phase III trials.
Bladder cancer.Patton, SE., Hall, MC., Ozen, H.[2022]
In a phase II study involving 27 patients with advanced transitional cell carcinoma, the sequential treatment of gemcitabine and carboplatin followed by paclitaxel resulted in an objective response rate of 40.7%, with one complete response and ten partial responses.
The treatment was generally safe, with hematologic toxicities being the most common, but the study concluded that while this sequential approach appears safer than triplet therapy, it did not significantly improve patient outcomes, indicating a need for further research with larger groups.
Sequential therapy with gemcitabine and Carboplatin followed by Paclitaxel as first line treatment for advanced urothelial cancer.Kattan, JG., Boutros, CY., Farhat, FS., et al.[2021]
In a study of 28 patients aged 65 and older with urothelial cancer, the combination of gemcitabine and cisplatin was found to be reasonably well-tolerated, with 57.1% receiving it in the neoadjuvant setting.
The study suggests that a lower dose of gemcitabine (1000 mg/mΒ²) is better tolerated than the standard higher dose (1250 mg/mΒ²), as higher doses led to more hematologic toxicity and treatment delays.
Tolerability of Gemcitabine Plus Cisplatin for Treatment of Urothelial Cancer in the Elderly Population.Jan, AS., Dolan, DE., Lombardi, K., et al.[2022]

Citations

Bladder cancer. [2022]
A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. [2021]
State-of-the-art management of metastatic disease at initial presentation or recurrence. [2022]
Sequential therapy with gemcitabine and Carboplatin followed by Paclitaxel as first line treatment for advanced urothelial cancer. [2021]
Tolerability of Gemcitabine Plus Cisplatin for Treatment of Urothelial Cancer in the Elderly Population. [2022]
Cis-diamminedichloroplatinum activity in bidimensionally measurable metastatic lesions of bladder carcinoma. [2022]
[Antitumor effect of combined use of purified human natural tumor necrosis factor (N-TNF) and cis-diamminedichoroplatinum (II) (cisplatin) on the implanted bladder carcinoma (MBT-2) in mice]. [2019]
[Phase II study on cis-diamminedichloroplatinum (II) by a collaborative study]. [2013]
[Phase II study of cis-diamminedichloroplatinum (II) in genitourinary cancer]. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
Boxing bladder cancer with COX-2-specific inhibition. [2021]
Cyclin-mediated G1 arrest by celecoxib differs in low-versus high-grade bladder cancer. [2021]
Enhanced inhibition of urinary bladder cancer growth and muscle invasion by allyl isothiocyanate and celecoxib in combination. [2021]
Cisplatin versus cisplatin combined with piroxicam in a canine model of human invasive urinary bladder cancer. [2013]
Celecoxib for the prevention of nonmuscle invasive bladder cancer: results from a matched control study. [2020]
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