Study on Gemcitabine and Docetaxel for High-Grade Bladder Cancer Unresponsive to BCG Treatment
Sponsor: Michael A. O'Donnell
ClinicalTrials ID:NCT07322263
This clinical trial is testing whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can effectively treat high-grade bladder cancer that hasn't responded to BCG therapy. The drugs are given directly into the bladder to see if they can prevent the cancer from returning and offer a non-surgical alternative to bladder removal.
Patient Parameters
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Program Overview
The aim of this study is to find out if using Gemcitabine and Docetaxel directly in the bladder can treat high-grade bladder cancer that hasn't responded to BCG treatment. Researchers want to see if this approach can stop the cancer from coming back and avoid the need for bladder removal surgery. Participants will receive weekly treatments for 6 weeks, and if the cancer responds, they will continue with monthly treatments for up to 2 years. The study will also monitor any side effects and long-term outcomes over 5 years.
Description
This study is testing a new treatment for high-grade bladder cancer that hasn't responded to BCG therapy. The treatment involves giving two chemotherapy drugs, Gemcitabine and Docetaxel, directly into the bladder. The main goal is to see if this can effectively treat the cancer and prevent it from coming back, offering an alternative to bladder removal surgery.
Participants will first go through a screening process, including tumor removal and imaging tests. They will then receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks. If the cancer responds, they will continue with similar monthly treatments for up to 2 years. Regular check-ups, including bladder exams, urine tests, and biopsies, will be conducted to monitor progress. Participants may also complete optional quality-of-life surveys.
If the cancer returns early, a second 6-week treatment cycle may be offered. The study will follow participants for up to 5 years to assess long-term outcomes, including cancer recurrence and survival rates.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-grade non-muscle-invasive bladder cancer that hasn't spread to the upper urinary tract or prostate.
- Cancer types include carcinoma in situ (CIS) with or without non-muscle-invasive tumors, or high-grade papillary tumors without CIS.
- All visible bladder tumors must be removed within 8 weeks before starting treatment.
- Cancer must have been unresponsive to BCG therapy, as defined by specific criteria.
- Must be eligible for bladder removal surgery but choose not to have it, or not be a candidate for surgery due to other health issues.
- Must be 18 years or older and able to understand and sign consent forms.
- Must have a performance status score of 2 or less, indicating good overall health.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during treatment and for 3 months after.
- Must not have received any intravesical or upper tract topical therapy within 8 weeks of starting the study.
- Must be willing to comply with all study requirements and provide necessary medical information.
Exclusion Criteria
- History of bladder cancer that has spread beyond the bladder muscle.
- History of cancer in the upper urinary tract or prostate.
- History of other types of bladder cancer, except for certain favorable types.
- Active or uncontrolled other cancers, except for certain non-threatening types.
- Severe allergic reactions to Gemcitabine, Docetaxel, or similar drugs.
- Recent treatment with other cancer therapies or major surgery.
- Poor organ or bone marrow function, as indicated by specific medical tests.
- History of radiation to the pelvis or difficulty with bladder catheterization.
- Active infections or recent COVID-19 infection.
- Significant heart disease or other major health issues.
- Pregnant or breastfeeding women.
- Participation in other research studies involving investigational drugs within 6 weeks of starting this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Iowa | 52242 | Iowa City | Iowa |
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