S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
- Interventional
- Active
- NCT02177695
Contact Information
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).
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.