A Phase II Study of Chemotherapy without Surgery in Patients with Muscle-Invasive Bladder Cancer and Certain Gene Mutations

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Full Title

A Phase II Study of Dose-Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations (A031701) (CIRB)

Purpose

The standard therapy for bladder cancer that invades the muscle wall (“muscle-invasive bladder cancer”) is chemotherapy followed by surgery to remove the bladder. The purpose of this study is to see if some patients with muscle-invasive bladder cancer can avoid surgery to remove their bladder. New research has shown that bladder tumors with changes in the genes called DNA damage response (DDR) genes are very sensitive to a chemotherapy treatment known as “dose-dense gemcitabine and cisplatin” (ddGC). In this study, researchers are testing whether patients whose tumors have a DDR gene mutation and whose bladder tumor shrinks after chemotherapy can keep the bladder and avoid surgery.

All patients will receive ddGC. Those who do not have DDR mutations will go on to receive either surgery or chemoradiation (more chemotherapy plus radiation therapy) after ddGC. For patients with DDR mutations, those who respond well to ddGC will not have surgery; those whose tumors do not respond well to ddGC will still have surgery. Chemotherapy with ddGC is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have muscle-invasive bladder cancer that has not metastasized and has not yet been treated with chemotherapy, immunotherapy, or radiation therapy.
  • Patients’ tumors must be operable.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gopa Iyer 646-422-4362.

Protocol

18-460

Phase

II

Investigator