A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
A randomized phase II, multi-center, open-label, study of docetaxel versus docetaxel/PR104.
Following informed consent, subjects will undergo baseline evaluation with history, physical
exams, blood work and disease assessment. Selected subjects will undergo PET imaging with
F18 fluoromisonidazole (F18-FMISO) and Fludeoxyglucose (FDG) for assessment of hypoxia and
glucose metabolism, and pharmacokinetics of PR104.
Subjects will be randomized between arm 1 consisting of docetaxel, 75 mg/m^2, administered
intravenously (IV), every 21 days (an approved dose and schedule) and arm 2 consisting of
docetaxel, 60 mg/m^2 with PR104 at 770 mg/m^2, IV, every 21 days. Subjects randomized to
PR104/docetaxel will receive prophylactic G-CSF. One cycle will be 21 days in duration.
Subjects will be evaluated weekly. A disease assessment will be performed every six weeks.
Subjects with progression will be removed from study. Subjects with a response or stable
disease may continue on study if this is considered beneficial by their physician.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone
Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Participants were followed for the duration on study, an average of 4 months
No
United States: Food and Drug Administration
PR104-2003
NCT00862134
March 2009
May 2010
Name | Location |
---|---|
Midwestern Regional Medical Center | Zion, Illinois 60099 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Northwestern University | Chicago, Illinois 60611 |
Scott & White Memorial Hospital | Temple,, Texas 76508 |
WJB Dorn VA Medical Center | Columbia, South Carolina 29209 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Annapolis Oncology Center | Annapolis, Maryland 21401 |
Sharp Clinical Oncology Research | San Diego, California 92123 |
Piedmont Hematology Oncology Associates, PLLC | Winston-Salem, North Carolina |
VA Sierra Nevada Health Care System | Reno, Nevada 89502 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Kalamazoo Hematology & Oncology | Kalamazoo, Michigan 49048 |
Montgomery Cancer Center | Mt. Sterling, Kentucky 40353 |
ACORN | Memphis, Tennessee 38138 |
VA Medical Center | Durham, North Carolina 27705 |
Orchard Research, LLC | Skokie, Illinois 60076 |
Texas Oncology - Allison Cancer Center | Midland, Texas 79701 |
University of Miami/Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
St. Francis Health Services | Beech Grove, Indiana 46107 |
McFarland Clinic/William R. Bliss Cancer Center | Ames, Iowa 50010 |
Iowa Blood & Cancer Care | Cedar Rapids, Iowa 52402 |
Baton Rouge General/Penington | Baton Rouge, Louisiana 70809 |
Lapidus Cancer Center/Sinai Hospital | Baltimore, Maryland 21215 |
Cincinnati VA Medical Center | Cincinnati, Ohio 45220 |