Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU10-147
OUTLINE: This is a multi-center study
Patients will be enrolled into one of two parallel cohorts:
- Cohort 1: impaired renal function AND poor performance status (cycle length = 28 days).
Everolimus 10 mg orally daily
- Cohort 2: impaired renal function OR poor performance status (cycle length = 28 days).
Everolimus 10 mg orally daily + IV Paclitaxel 80 mg/m2 on D1, 8, 15
Restaging evaluations will be performed after every 2 cycles.
Treatment will continue until disease progression or unacceptable toxicity.
Karnofsky performance status 60-70%
Life Expectancy: Not specified
Hematopoietic:
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100 K/mm3
- INR ≤ 1.5 (Anticoagulants are allowed if target INR ≤ 1.5 on a stable dose of warfarin
or on a stable dose of Low molecular weight (LMW) heparin for at least 2 weeks prior to
registration for protocol therapy).
- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L
- Fasting triglycerides ≤ 2.5 x ULN.
- Fasting serum glucose < 1.5 x ULN
Hepatic:
- Bilirubin ≤ 1.5 x ULN
- Aminotransferases (AST and ALT) ≤ 2.5 x ULN (unless liver metastases, then ≤ 5 x ULN)
Renal:
- Calculated creatinine clearance of < 60 using the Cockcroft-Gault formula
Cardiovascular:
- No symptomatic congestive heart failure of New York heart Association Class III or IV.
- No unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction within 6 months of start of study drug, serious uncontrolled cardiac
arrhythmia or any other clinically significant cardiac disease.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
To evaluate clinical benefit rate (complete response, partial response, and stable disease) at 4 months from initiation of treatment.
4 months
No
Matthew Galsky, M.D.
Study Chair
Hoosier Oncology Group
United States: Institutional Review Board
HOG GU10-147
NCT01215136
December 2010
December 2013
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
MUSC Hollings Cancer Center | Charleston, South Carolina 29425 |
Northwestern University, Robert H. Lurie Comprehensive Cancer Center | Chicago, Illinois 60611 |
IU Health Central Indiana Cancer Centers | Indianapolis, Indiana 46219 |
Metro Health Cancer Care | Wyoming, Michigan 49519 |
Tisch Cancer Institute at Mount Sinai Medical Center | New York, New York 10029 |
University of Alabama Hematology Oncology Clinic at Medical West | Birmingham, Alabama 35294 |