A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40
OUTLINE: This is a multi-center study.
- Dexamethasone and antiemetic premedication1.
- Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle
- Capecitabine: 825 mg/m2 po BID Days 1-14
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of
therapy
Performance status: ECOG performance status 0 or 1
Life expectancy: At least 3 months
Hematopoietic:
- ANC of > 1,500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 8 gm/dl
Hepatic:
- Total Bilirubin £ ULN
- Albumin > 3
- Maximum Alk Phos > 2.5 x < 5 x ULN
Renal:
- Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)
Cardiovascular:
- No decompensated congestive heart failure or active angina.
- Clinically significant cardiac disease not well controlled with medication (eg.
congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias)
or myocardial infarction in the past 12 months is not allowed.
Pulmonary:
- Not specified
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine
24 months
No
David Potter, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG HN02-40
NCT00216138
March 2004
September 2007
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Helen F. Graham Cancer Center | Newark, Delaware 19713 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Chicago | Chicago, Illinois 60637 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Providence Medical Group | Terre Haute, Indiana 47802 |
Elkhart Clinic | Elkhart, Indiana 46515 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Center for Cancer Care, Inc., P.C. | New Albany, Indiana 47150 |
AP&S Clinic | Terre Haute, Indiana 47804 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Center for Hematology-Oncology of S Michigan | Jackson, Michigan 49201 |