NCT02567409

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

A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the addition of berzosertib (M6620 \[VX-970\]) to cisplatin/gemcitabine hydrochloride (gemcitabine) improves progression-free survival (PFS) relative to cisplatin/gemcitabine alone. SECONDARY OBJECTIVES: I. To compare overall survival (OS) with the addition of M6620 (VX-970) to cisplatin/gemcitabine relative to cisplatin/gemcitabine alone. II. To compare tumor response rate with the addition of M6620 (VX-970) to cisplatin/gemcitabine relative to cisplatin/gemcitabine alone. III. To compare safety with the addition of M6620 (VX-970) to cisplatin/gemcitabine relative to cisplatin/gemcitabine alone. IV. To assess the role of p53 status in predicting response to M6620 (VX-970)-based therapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive gemcitabine hydrochloride intravenously (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. ARM B: Patients receive gemcitabine hydrochloride and cisplatin as in Arm A. After completion of study treatment, patients are followed up to 36 months.

Conditions

• Metastatic Bladder Urothelial Carcinoma
• Metastatic Renal Pelvis and Ureter Urothelial Carcinoma
• Metastatic Ureter Urothelial Carcinoma
• Stage IV Bladder Urothelial Carcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	Berzosertib	Given IV
DRUG	Cisplatin	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV

Timeline

• Start date: 2017-01-31
• Primary completion: 2023-04-21
• Completion: 2023-04-25
• First posted: 2015-10-05
• Last updated: 2025-03-03
• Results posted: 2023-10-17

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study