Cisplatin + Gemcitabine +/- Berzosertib for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of treatment with cisplatin and gemcitabine, with or without a new drug called berzosertib, for people with urothelial cancer that has spread. Cisplatin and gemcitabine are chemotherapy drugs that stop cancer cells from growing and spreading. Researchers are testing berzosertib to see if it can enhance this effect by blocking certain enzymes that aid cancer cell growth. Individuals diagnosed with metastatic urothelial cancer, who have not yet received chemotherapy for it and have measurable cancer, might be suitable for this study. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important advancements in cancer therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you should avoid taking strong inhibitors or inducers of CYP3A4, as they may interact with the trial drugs. It's important to discuss your current medications with the study team to ensure there are no interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that patients generally tolerate the combination of cisplatin and gemcitabine well, meaning most people can handle it without serious issues. Studies have found this combination to be safe, with manageable side effects. For instance, one study found that this pair worked well and was tolerated by patients with various types of cancer.
Regarding berzosertib, research found that adding it to gemcitabine was also well-tolerated by patients with advanced solid tumors. This suggests that using cisplatin, gemcitabine, and berzosertib together does not cause significantly more severe side effects than using just cisplatin and gemcitabine.
Overall, treatments in this trial have been tested in other contexts and have demonstrated a reasonable safety profile based on previous research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they introduce berzosertib to the standard chemotherapy regimen for bladder cancer. Unlike the usual treatment with just cisplatin and gemcitabine, berzosertib is an ATR kinase inhibitor that might enhance the effectiveness of chemotherapy by preventing cancer cells from repairing themselves after treatment. This unique mechanism could potentially increase the treatment's ability to stop or slow down cancer progression more effectively than current options. By combining berzosertib with traditional chemotherapy drugs, researchers are hopeful for improved outcomes for patients with bladder cancer.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
Studies have shown that using cisplatin and gemcitabine together effectively treats advanced bladder cancer. Patients receiving this combination, one of the treatment arms in this trial, have a 41% chance of tumor reduction, with about 22% experiencing a complete response, meaning their cancer disappears. Another trial arm includes adding berzosertib to the cisplatin and gemcitabine regimen. However, research indicates that berzosertib does not significantly extend the time patients live without cancer progression or increase overall survival. In short, cisplatin and gemcitabine work well together, but berzosertib does not provide extra benefits.12467
Who Is on the Research Team?
Sumanta K. Pal
Principal Investigator
City of Hope Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with metastatic urothelial carcinoma, including cancers from the bladder, ureter, or upper tract. Participants must not have had chemotherapy for metastatic disease but may have had immunotherapy. They should be in good physical condition (Karnofsky >= 70%), have proper organ function, and no severe illnesses that could interfere with the study. Women of childbearing potential and men must use effective contraception during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive gemcitabine hydrochloride and cisplatin, with or without berzosertib, in 21-day cycles for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Berzosertib
- Cisplatin
- Gemcitabine Hydrochloride
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor