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

Not Recruiting

Trial ID: NCT02177695

Purpose

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.

Official Title

A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) With Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer

Stanford Investigator(s)

Eila C. Skinner
Eila C. Skinner

Thomas A. Stamey Research Professor of Urology

Alice C. Fan
Alice C. Fan

Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Harcharan Gill
Harcharan Gill

Kathryn Simmons Stamey Professor, Emeritus

Eligibility


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.

   - 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

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.

Intervention(s):

drug: Gemcitabine

drug: Cisplatin

drug: Methotrexate

drug: Vinblastine

drug: Doxorubicin

drug: Filgrastim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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