S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02177695

Run by

SWOG Cancer Research Network

People needed

237

Starts

2014-08-28

Expected to finish

2022-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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 20 (10 micron) slides plus 2 (5 micron) slides from the start and end of the 20 slides for a total of 22 unstained slides.
• 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

You may not qualify if…

• 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.

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• University of Arizona Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• University of Arizona Cancer Center-Orange Grove Campus — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• Yuma Cancer Center — Yuma, Arizona, United States
• Fowler Family Center for Cancer Care — Jonesboro, Arkansas, United States
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• City of Hope Antelope Valley — Lancaster, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States
• Stanford Cancer Institute — Palo Alto, California, United States
• PCR Oncology — Pismo Beach, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Stanford Cancer Center South Bay — San Jose, California, United States
• City of Hope South Pasadena — South Pasadena, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Rocky Mountain Cancer Centers-Aurora — Aurora, Colorado, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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