A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer
The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient's response to chemotherapy before surgery.
The COXEN program will not select a patient's therapy, but the type of chemotherapy that he/she will receive will be randomly decided. The patient's response to chemotherapy will be used to test the usefulness of the COXEN program, which is the main goal of this trial. Other potential tests to predict a patient's response to chemotherapy will also be evaluated. In this study, the patient may receive the treatment in Arm 1 (gemcitabine and cisplatin) or the treatment in Arm 2 [methotrexate, vinblastine, doxorubicin, cisplatin, and filgrastim (or pegfilgrastim)]. There will be about 230 people taking part in this study (115 in each arm).
Inclusion Criteria:
Exclusion Criteria:
Sacramento, California 95817, United States
Aurora, Colorado 80045, United States
Englewood, Colorado 80113, United States
Pekin, Illinois 61554, United States
Brownstown, Michigan 48183, United States
East China Township, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
Jefferson City, Missouri 65109, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Spartanburg, South Carolina 29307, United States
Johnson City, Tennessee 37604, United States
Kingsport, Tennessee 37660, United States
Houston, Texas 77030, United States
San Antonio, Texas 78229, United States
Berlin Corners, Vermont 05602, United States
Stevens Point, Wisconsin 54481, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States