A Phase II Trial of Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer: Hoosier Oncology Group GU04-75
OUTLINE: This is a multi-center study.
- Cisplatin 70 mg/m2 Day 1
- Gemcitabine 1250 mg/m2 Day 1 and 8
- Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles
(every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24
weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of
cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every
three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
If at any time patient has undue toxicity or progressive disease, patient will be removed
from the study and followed until progression and for survival.
If the patient has Grade 3 or 4 neurotoxicity and/or the creatinine rises above 2.0, then
the cisplatin will be discontinued and the patient continued on study and treated with
gemcitabine and bevacizumab at the same dose and schedule.
ECOG Performance Status 0 or 1
- White blood cell count > 3000/mm3
- Absolute neutrophil count (ANC) > 1500 mm/3
- Platelet count > 100,000/mm3
- Hemoglobin > 8 g/dL (may be transfused or receive erythropoietin support to maintain or
exceed this level).
- INR < 1.5
- No full dose/therapeutic anticoagulation with either low molecular weight heparin or
unfractionated heparin or coumadin
- Total bilirubin of <1.5 mg/dL
- ALT <5 times upper limit of normal for subjects with documented liver metastases; <2.5
times the upper limit of normal for subjects without evidence of liver metastases.
- Serum creatinine of < 1.5 mg/dL.
- Urine protein:creatinine ratio < 1.0 at screening
- No history of myocardial infarction or stroke within the last 6 months
- No uncontrolled hypertension (blood pressure of >160 systolic and/or 110 diastolic mmHg
- No unstable angina, New York Heart Association (NYHA) Grade II or greater congestive
- No unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial
arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are
eligible), or clinically significant peripheral vascular disease.
- Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- To determine the progression free survival of patients with metastatic transitional cell cancer treated with cisplatin, gemcitabine and bevacizumab.
Christopher Sweeney, M.B.B.S.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|University of Chicago||Chicago, Illinois 60637|
|Oncology Hematology Care, Inc.||Cincinnati, Ohio 45219|
|Arnett Cancer Care||Lafayette, Indiana 47904|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|Quality Cancer Center (MCGOP)||Indianapolis, Indiana 46202|
|AP&S Clinic||Terre Haute, Indiana 47804|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|