Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101
Outline: This is a multi-center study.
Patients who meet eligibility criteria will receive treatment as follows until disease
progression or excessive toxicities:
- Erlotinib 150 mg p.o. daily on days 2-7, 9-14, 16-28
- Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8, 15
Treatment cycle = 28 days
Performance Status: ECOG performance status 0 to 2
Life expectancy: At least 12 weeks
Hematopoietic:
- Absolute neutrophil count (ANC) > 1000 mm3
- Platelet count > 75,000 mm3
- Hemoglobin > 8 g/dL
Hepatic:
- Bilirubin < 2.0 x upper limit of normal (ULN)
- Transaminases (AST, ALT) < 5.0 x ULN if alkaline phosphatase is < 2.5 x ULN, or
alkaline phosphatase < 5 x ULN if transaminases are < 1.5 x ULN.
- If not on anticoagulation: PT < 4 seconds above ULN; INR < 1.5; PTT < 1.3 x ULN.
- If on therapeutic anticoagulation, patients may have an INR > 1.5 and PTT within
therapeutic range; INR will be monitored weekly until stable.
- Serum Albumin > 3.0
Renal:
- Creatinine clearance of > 60 ml/ min (by Cockcroft-Gault)
Pulmonary:
- Not specified
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel.
18 months
No
Elena Gabriela Chiorean, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
GI06-101
NCT00532441
September 2007
August 2010
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Northwestern University Feinberg School of Medicine | Chicago, Illinois 60611 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
IN Onc/Hem Associates | Indianapolis, Indiana 46202 |
Rush-Presbyterian St. Luke's Medical Center | Chicago, Illinois 60612 |