Spots Global Cancer Trial Database for Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer
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Trial Identification
Brief Title: Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer
Official Title: A Randomized Phase 2 Trial of Cisplatin/Gemcitabine With or Without M6620 (VX-970) in Metastatic Urothelial Carcinoma
Study ID: NCT02567409
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Keck Medical Center of USC Pasadena, Pasadena, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Nebraska Medicine-Bellevue, Bellevue, Nebraska, United States
Nebraska Medicine-Village Pointe, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Contact Details
Name: Sumanta K Pal
Affiliation: City of Hope Comprehensive Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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