Gemcitabine + Carboplatin for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a chemotherapy combination called gemcitabine and carboplatin (GC) can effectively treat advanced bladder cancer in individuals who have tried other treatments. The study aims to determine if GC can shrink the cancer or halt its growth and to identify any side effects. Participants must have bladder cancer that has spread or is locally advanced and must have already received treatment with enfortumab vedotin and pembrolizumab. This research could enhance future treatment options for individuals with this type of cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot be on other investigational drugs or have had certain treatments within two weeks before starting the trial.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the combination of gemcitabine and carboplatin is generally well-tolerated by people with advanced cancers. In various studies, many patients experienced manageable side effects. These side effects include a decrease in blood cell counts, tiredness, and mild nausea, which are common with many chemotherapy treatments.
One study found that nearly half of the patients experienced some tumor shrinkage with this combination. Another study reported that 36% of patients saw their cancer shrink or stop growing temporarily.
This trial is in Phase 2, indicating that the treatment has already demonstrated some safety in earlier studies. This phase aims to further explore the treatment's effectiveness and safety. Gemcitabine and carboplatin have been tested in other cancers and are FDA-approved for those uses, providing additional safety reassurance for this trial.
Overall, while side effects may occur, the treatment is considered safe enough to continue exploring its benefits for bladder cancer.12345Why do researchers think this study treatment might be promising for bladder cancer?
Researchers are excited about the combination of gemcitabine and carboplatin for bladder cancer because it offers a potentially effective treatment option with a different approach than standard chemotherapy regimens like cisplatin. This combination uses gemcitabine, which disrupts cancer cell DNA, paired with carboplatin, which enhances the disruption by forming DNA cross-links. This dual mechanism targets cancer cells more aggressively, potentially improving outcomes for patients who cannot tolerate cisplatin. Additionally, this regimen is administered every three weeks, which may be more convenient and reduce side effects compared to more frequent dosing schedules of other treatments.
What evidence suggests that gemcitabine and carboplatin could be effective for advanced bladder cancer?
Research has shown that using gemcitabine and carboplatin together can effectively treat advanced bladder cancer. In one study, this treatment helped nearly half of the patients, with 46.2% experiencing tumor shrinkage or halted growth. Another study found that patients lived for an average of 7.5 months without cancer progression. Additionally, the average overall survival time was 9.3 months. This trial will evaluate the effectiveness of gemcitabine and carboplatin in managing cancer, even after treatments like enfortumab vedotin and pembrolizumab have been tried.14678
Who Is on the Research Team?
Daniel Geynisman, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced urothelial carcinoma who have measurable disease and previously received EVP treatment. They should be relatively healthy (ECOG 0-2) and have normal organ/marrow function, but can join within 28 days of the last EVP treatment or with ongoing side effects if safe.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine and carboplatin chemotherapy every 3 weeks until disease progression or other protocol conditions apply
Follow-up
Participants are monitored for survival, cancer control, and quality of life after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Gemcitabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor