Study on Intravesical Cabazitaxel, Gemcitabine, and Cisplatin for Treating Bladder Cancer
Sponsor: Guarionex J. Decastro
ClinicalTrials ID:NCT02202772
This clinical trial is testing a new combination of drugs delivered directly into the bladder to treat bladder cancer that hasn't responded to standard treatments. The study aims to find out if this approach is safe and effective for patients with non-muscle invasive bladder cancer.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment that combines three drugs—Cabazitaxel, Gemcitabine, and Cisplatin—administered directly into the bladder. This treatment is for patients with bladder cancer that has not responded to Bacillus Calmette-Guerin (BCG) therapy, a common treatment for this type of cancer. The study will involve up to 24 patients and will test different doses and treatment cycles to find the best approach.
Description
For patients with bladder cancer that doesn't respond to BCG therapy, the usual option is to remove the bladder, which can have significant risks and impact quality of life. Previous attempts to treat this type of cancer with single drugs have shown limited success. This study is exploring a new approach by combining three drugs—Cabazitaxel, Gemcitabine, and Cisplatin—administered directly into the bladder. Researchers believe that using multiple drugs together may improve treatment outcomes and help patients live longer.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of non-muscle invasive bladder cancer.
- Includes patients with high-grade or low-grade papillary tumors or carcinoma in situ (CIS).
- Cancer must not have responded to BCG treatment or must have returned after initial success with BCG.
- Must have had some form of standard bladder treatment, including at least one course of BCG.
- Must be eligible for bladder removal surgery but choose not to have it, or be unable to have surgery due to other health issues.
- All visible cancer in the bladder must be removed before starting the study.
- Must be 18 years or older and able to understand and sign consent forms.
- Must have a good overall health status (ECOG score of 0 or 1).
- Women of childbearing age must have a negative pregnancy test and agree to use effective birth control during and for three months after the study.
- No experimental bladder treatments within six weeks before joining the study.
Exclusion Criteria
- Severe allergic reactions to similar drugs (e.g., docetaxel or drugs containing polysorbate 80).
- Currently taking or planning to take certain medications that affect liver enzymes.
- Have another cancer diagnosed within six months before joining the study.
- Currently receiving any other chemotherapy.
- Poor organ or bone marrow function, as shown by specific blood test results.
- Pregnant or breastfeeding women.
- History of certain urinary tract conditions, like vesicoureteral reflux or having a urinary stent.
- Participating in another research study with an investigational drug within six weeks before joining this study.
- Must have signed an approved consent form to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Columbia University Irving Medical Center - HIP | 10032 | New York | New York |
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