Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Oncology Group GU10-148
OUTLINE: This is a multi-center study
Gemcitabine 1000 mg/m2 Days 1 & 8 Cisplatin 70 mg/m2 Day 1 Ipilimumab 10 mg/kg Day 1 (start
cycle 3)
Treatment during the induction phase will be administered in six 21-day cycles. During
cycles 1 and 2, gemcitabine plus cisplatin will be administered WITHOUT ipilimumab. During
cycles 3-6, combination therapy with gemcitabine, cisplatin, plus ipilimumab will be
administered. Patients without evidence of disease progression (by irRC) after completion
cycle 6 will continue single-agent ipilimumab maintenance every 3 months.
Karnofsky performance status (KPS) ≥ 80% within 14 days prior to registration for protocol
therapy.
Life Expectancy: Not Specified
Hematopoietic:
- White blood cell count (WBC) ≥ 3.5K/mm3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥ 100K/mm3
- Absolute neutrophil count (ANC) ≥ 1.5k/mm3
Hepatic:
- Bilirubin ≤ 1.5 times x Upper Limit of Normal (ULN) (except patients with Gilbert's
Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN. NOTE: If the patient has liver
metastases present, then ≤ 5 x ULN
Renal:
- Calculated creatinine clearance of ≥ 55 cc/min using the Cockcroft-Gault formula
Cardiovascular: Not Specified
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
One-Year Overall Survival
To determine the 1-year overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab.
12 months
No
Matthew Galsky, M.D.
Study Chair
Hoosier Oncology Group
United States: Institutional Review Board
GU10-148
NCT01524991
January 2012
June 2014
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Texas Oncology, PA | Dallas, Texas 75246-2006 |
Indiana University Melvin & Bren Simon Cancer Center | Indianapolis, Indiana 46202 |
IU Health Central Indiana Cancer Centers | Indianapolis, Indiana 46219 |
Tisch Cancer Institute at Mount Sinai Medical Center | New York, New York 10029 |
IU Health Goshen Hospital | Goshen, Indiana 46527 |