S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Bladder Cancer, Neoadjuvant Chemotherapy, Coexpression Extrapolation, COXEN, S1314, SWOG
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gemcitabine Type: Drug
Name: Cisplatin Type: Drug
Name: Methotrexate Type: Drug
Name: Vinblastine Type: Drug
Name: Doxorubicin Type: Drug
Name: Filgrastim Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
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 184 people taking part in this study (92 in each arm).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma histologies are excluded).

- Stage cT2-T4a N0 M0 disease.

- Documented muscle invasive disease with at least one of the following: disease measuring at least 10 mm on cross-sectional imaging OR the presence of tumor-associated hydronephrosis.

- Must be planning to receive a cystectomy from a urologist who has performed at least 50 cystectomies in the past 3 years, and the urologist must plan to remove at least 12 lymph nodes as part of surgery.

- Staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest within 56 days prior to registration. If alkaline phosphatase is above the treating institution's upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration.

- Performance status = 0 or 1

- 18 years of age or older

- Must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of two TUR formal-fixed paraffin embedded (FFPE) tissue blocks (at least one must contain a viable tumor that is at least 1 cm3 in size.

- Must agree to collection of tissue (if residual disease is present), urine, and whole blood.

- Must agree to participate in the translational medicine studies outlined in the protocol

Exclusion Criteria:

- Prior systemic cytotoxic chemotherapy or systemic anthracycline

- Peripheral neuropathy >/= Grade 2

- Class III/IV heart failure or known left ventricular ejection fraction (LVEF) < 50%

- Clinically relevant hearing impairment > Grade 2

- Renal function, calculated creatinine clearance < 60 mL/min

- Hepatic function, total bilirubin > 1.5 x institutional upper limit of normal (IULN) (or > 2.5 x IULN with Gilbert's disease); AST & ALT > 2 X IULN

- Hematologic function, absolute neutrophil count (ANC) < 1,500/mcL, hemoglobin < 9 g/dL, and platelets < 100,000/mcL

- Hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim

- Incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.)

- Pregnant or nursing females

- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. However, patients with localized prostate cancer who are being followed by an active surveillance program are eligible.
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Guru P. Sonpavde - 205-934-0309
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States
Status: Recruiting
Contact: Parminder Singh - 520-626-9008
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States
Status: Recruiting
Contact: Parminder Singh - 520-626-9008
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Status: Recruiting
Contact: Parminder Singh - 520-626-9008
UC San Diego Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
Contact: Frederick E. Millard - 858-822-5354 - cancercto@ucsd.edu
Los Angeles County-USC Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Siamak Daneshmand - 323-865-0451
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Status: Recruiting
Contact: Siamak Daneshmand - 323-865-0451
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Status: Recruiting
Contact: Thomas W. Flaig - 720-848-0650
Sibley Memorial Hospital
Washington, District of Columbia, United States
Status: Recruiting
Contact: Noah M. Hahn - 410-955-8804 - jhcccro@jhmi.edu
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Pali Momi Medical Center
Aiea, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Leeward Radiation Oncology Center
Ewa Beach, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Kuakini Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Queen's Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Straub Clinic and Hospital
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Status: Recruiting
Contact: Jeffrey L. Berenberg - 808-586-2979
Kootenai Cancer Center
Post Falls, Idaho, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Status: Recruiting
Contact: Peter H. O'Donnell - 773-834-7424
Loyola University Medical Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Elizabeth Henry - 708-226-4357
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
UC Comprehensive Cancer Center at Silver Cross
New Lennox, Illinois, United States
Status: Recruiting
Contact: Peter H. O'Donnell - 773-834-7424
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Status: Recruiting
Contact: Donald B. Wender - 712-252-0088
Maine Center for Cancer Medicine-Scarborough
Scarborough, Maine, United States
Status: Recruiting
Contact: Frederick R. Aronson - research@newecs.org
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Noah M. Hahn - 410-955-8804 - jhcccro@jhmi.edu
University of Michigan University Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Ajjai S. Alva - 800-865-1125
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
CoxHealth Cancer Center
Branson, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Freeman Health System
Joplin, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Mercy Hospital-Joplin
Joplin, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Phelps County Regional Medical Center
Rolla, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Joel Picus - 800-600-3606 - info@siteman.wustl.edu
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Washington University School of Medicine
Saint Louis, Missouri, United States
Status: Recruiting
Contact: Joel Picus - 800-600-3606 - info@siteman.wustl.edu
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States
Status: Recruiting
Contact: Joel Picus - 800-600-3606 - info@siteman.wustl.edu
CoxHealth South Hospital
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Mercy Hospital Springfield
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Billings Clinic Cancer Center
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Montana Cancer Consortium CCOP
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Saint Vincent Healthcare
Billings, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Saint Peter's Community Hospital
Helena, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Kalispell Regional Medical Center
Kalispell, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
21st Century Oncology - Henderson
Henderson, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
21st Century Oncology - Fort Apache
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
21st Century Oncology - Vegas Sunrise
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
21st Century Oncology - Vegas Tenaya
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Cancer and Blood Specialists-Fort Apache
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Status: Recruiting
Contact: John A. Ellerton - 702-384-0013
University of Rochester
Rochester, New York, United States
Status: Recruiting
Contact: Jonathan W. Friedberg - 585-275-5830
State University of New York Upstate Medical University
Syracuse, New York, United States
Status: Recruiting
Contact: Rahul Seth - 315-464-5476
Sampson Radiation Oncology
Clinton, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Onslow Memorial Hospital
Jacksonville, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Status: Recruiting
Contact: James N. Atkins - 919-580-0000
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Christopher Y. Thomas - 434-243-6143
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Status: Recruiting
Contact: Anjali S. Advani - 866-223-8100
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Sindhu Singh - 405-271-4272 - julie-traylor@ouhsc.edu
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Status: Recruiting
Contact: Sindhu Singh - 405-271-4272 - julie-traylor@ouhsc.edu
SWOG
Portland, Oregon, United States
Status: Not yet recruiting
Contact: Thomas W. Flaig - 303-724-3808 - thomas.flaig@ucdenver.edu
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Lewistown Hospital
Lewistown, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Jean H. Hoffman-Censits - 215-955-6084
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Geisinger Medical Group
State College, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
Status: Recruiting
Contact: Christian S. Adonizio - 570-271-5251
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Memorial Hospital
Greenville, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Status: Recruiting
Contact: Jeffrey K. Giguere - 864-241-6251
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, United States
Status: Recruiting
Contact: Asheesh Shipstone - 423-578-8538
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City, Tennessee, United States
Status: Recruiting
Contact: Asheesh Shipstone - 423-578-8538
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Status: Recruiting
Contact: Asheesh Shipstone - 423-578-8538
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee, United States
Status: Recruiting
Contact: Asheesh Shipstone - 423-578-8538
Baylor College of Medicine
Houston, Texas, United States
Status: Recruiting
Contact: Anita L. Sabichi - 713-792-3245 - burton@bcm.edu
Ben Taub General Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Anita L. Sabichi - 713-792-3245 - burton@bcm.edu
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Woondong Jeong - 210-450-3800
University Hospital
San Antonio, Texas, United States
Status: Recruiting
Contact: Woondong Jeong - 210-450-3800
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Status: Recruiting
Contact: Woondong Jeong - 210-450-3800
Southwest VA Regional Cancer Center
Norton, Virginia, United States
Status: Recruiting
Contact: Asheesh Shipstone - 423-578-8538
Welch Cancer Center
Sheridan, Wyoming, United States
Status: Recruiting
Contact: Benjamin T. Marchello - 800-648-6274
Start Date
July 2014
Sponsors
Southwest Oncology Group
Source
Southwest Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page