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Protocol No. NCI9947

Principal Investigator Emamekhoo, Hamid

Phase II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Randomized Phase 2 Trial of Cisplatin/Gemcitabine with or without VX-970 in Metastatic Urothelial Carcinoma

Objective The purpose of this study is to compare any good and bad effects of using VX-970 along with the usual chemotherapy compared to usual chemotherapy alone. People who are not in a study are usually treated with a chemotherapy regimen that is FDA approved comprised of cisplatin and gemcitabine. This study will allow the researchers to know more about adding VX-970.

Treatment VX-970 is an experimental drug that has not been approved by the FDA for any cancer.

Description This study has two study groups. A computer will by chance assign you to a treatment group in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. You have a 50% chance of being assigned to Group 1 and a 50% chance of being assigned to Group 2. Group 1 will receive the study drug VX-970 in combination with chemotherapy (cisplatin and gemcitabine) and Group 2 will receive chemotherapy alone (cisplatin and gemcitabine).

Key Eligibility
  • 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 is allowed
  • At least 12 months have elapsed since platinum-based peri-operative treatment
  • Radiotherapy within 4 weeks of protocol therapy is not allowed
  • Patients with ≥ Grade 2 neuropathy are ineligible
  • Patients are excluded if they have uncontrolled intercurrent illness including, but not limited to, ongoing or active
  • infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Applicable Disease Sites Bladder

Therapies Involved Cytotoxic Chemotherapy; Other

Drugs Involved VX-970; cis-diamminedichloroplatinum (cisplatin); cisplatin; gemcitabine; gemzar (gemcitabine); platinol (cisplatin); platinum (cisplatin)

Status Open

Participating Institutions UW Hospital and Clinics