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Alkylating agent

Cisplatin + Gemcitabine +/- Berzosertib for Bladder Cancer

Phase 2

Waitlist Available

Led By Sumanta K Pal

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed metastatic urothelial carcinoma; urothelial cancer derived from the bladder, ureter or upper tract is permitted

No prior cytotoxic chemotherapy for metastatic disease; prior immunotherapy is permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

Study Summary

This trial is testing cisplatin + gemcitabine with or without berzosertib to see if it's effective in treating patients with urothelial cancer that has spread.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Cisplatin can cause kidney damage, hearing loss, nausea, vomiting; gemcitabine's side effects include flu-like symptoms, rash, low blood counts leading to infection risk; berzosertib's potential side effects aren't fully known but may include fatigue and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer originates from the bladder, ureter, or upper tract and has spread.

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I haven't had chemotherapy for my advanced cancer, but I may have had immunotherapy.

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It has been over a year since I had platinum-based treatment around surgery time.

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My kidney function, measured by creatinine clearance, is good.

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I agree to use birth control during and up to 6 months after the study.

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I have a tumor that can be measured with scans or exams.

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I am mostly independent and can carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Confirmed Objective Response Rate

Overall Survival (OS)

Treatment Limiting Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (gemcitabine hydrochloride, cisplatin)Experimental Treatment2 Interventions

Patients receive gemcitabine hydrochloride and cisplatin as in Arm A.

Group II: Arm A (berzosertib, gemcitabine hydrochloride, cisplatin)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Berzosertib

2021

Completed Phase 2

~80

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,066 Total Patients Enrolled

Sumanta K PalPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO

9 Previous Clinical Trials

266 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02567409 — Phase 2

Bladder Cancer Research Study Groups: Arm B (gemcitabine hydrochloride, cisplatin), Arm A (berzosertib, gemcitabine hydrochloride, cisplatin)

Bladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02567409 — Phase 2

Cisplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02567409 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are actively involved in this clinical research project?

"This research project is now closed for recruitment. It was initially posted on August 19th 2016 and last modified July 13 2022. Alternative trials are available, with 2,505 actively enrolling people diagnosed with carcinoma and 1,037 for Cisplatin alone admitting volunteers."

Answered by AI

Is enrollment open to participants for this experiment?

"Sadly, this protocol is not currently recruiting candidates. Although it was initially posted on August 19th 2016 and modified as recently as July 13th 2022, 3542 other trials are actively searching for participants at the moment."

Answered by AI

Are there any North American medical facilities currently conducting this research experiment?

"Currently, this medical trial is accessible at 40 distinct locations. Examples of cities with local clinics are Boston, Charlottesville and Madison among other places. To reduce travel demand for participants' convenience, we recommend selecting the closest clinic to you upon enrollment."

Answered by AI

What perils are associated with the use of Cisplatin for medical treatment?

"Due to the lack of clinical data supporting effectiveness, our team assigned Cisplatin a score of 2 on its safety scale. This is because this trial falls under Phase 2 and there is only limited information demonstrating safety."

Answered by AI

Are there any prior experiments involving Cisplatin that have yielded noteworthy results?

"To date, 1037 clinical trials are currently running research into Cisplatin. 350 of these investigations have reached Phase 3 thus far, and they span across 53703 different sites with the majority situated in Shanghai."

Answered by AI

In what situations is Cisplatin typically prescribed to patients?

"Cisplatin is often used to manage neoplasm metastasis and has also demonstrated efficacy in fighting urinary bladder cancer, advanced testicular tumours, and small cell lung carcinoma."

Answered by AI

Recent research and studies

JAMA OncologyJournal

Effect of Cisplatin and Gemcitabine with or Without Berzosertib in Patients with Advanced Urothelial Carcinoma

Pal, Sumanta K., Paul H. Frankel, Amir Mortazavi, Matthew Milowsky, Ulka Vaishampayan, Mamta Parikh, Yung Lyou, et al.. 2021. “Effect of Cisplatin and Gemcitabine with or Without Berzosertib in Patients with Advanced Urothelial Carcinoma”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2021.3441.

JAMA OncologyJournal

Effect of Cisplatin and Gemcitabine with or Without Berzosertib in Patients with Advanced Urothelial Carcinoma

clinicaltrials.govStudy

Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer

2016. "Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02567409.