Cisplatin + Gemcitabine +/- Berzosertib for Bladder Cancer

Recruiting at 42 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Radiotherapy, Investigational agents, Allergic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

87 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without berzosertib works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with berzosertib in treating patients with urothelial cancer.

Research Team

Sumanta K. Pal

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Eligibility Criteria

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

Life expectancy of greater than 3 months

Absolute neutrophil count >= 1,500/mcL

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

Exclusion Criteria

I have moderate to severe nerve pain or damage.

Patients who are receiving any other investigational agents

I am allergic to M6620, cisplatin, or gemcitabine, or similar drugs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive gemcitabine hydrochloride and cisplatin, with or without berzosertib, in 21-day cycles for up to 6 cycles

18 weeks

6 cycles, each with multiple visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Treatment Details

Interventions

• Berzosertib
• Cisplatin
• Gemcitabine Hydrochloride

Trial Overview The trial is testing how well cisplatin and gemcitabine hydrochloride work alone compared to when combined with berzosertib in treating metastatic urothelial cancer. Cisplatin and gemcitabine are chemotherapy drugs; berzosertib blocks enzymes needed by cancer cells to grow.

Participant Groups

Group I: Arm B (gemcitabine hydrochloride, cisplatin) Experimental Treatment 2 Interventions

Patients receive gemcitabine hydrochloride and cisplatin as in Arm A.

Group II: Arm A (berzosertib, gemcitabine hydrochloride, cisplatin) Experimental Treatment 3 Interventions

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and cisplatin IV over 60 minutes on day 1. Patients also receive berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

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

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+