A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer
- Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB
or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without
- Compare the feasibility of these regimens, in terms of febrile neutropenia and
treatment delays, in these patients.
- Compare the objective response rate in patients treated with these regimens.
- Compare the survival and failure-free survival of patients treated with these regimens.
- Compare the toxicity profile of these regimens in these patients.
- Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1
and pegfilgrastim subcutaneously (SC) on day 2.
- Arm II*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and
dimesna IV over 30 minutes on day 1.
NOTE: *In both arms, darbepoetin alfa is administered SC on day 1 of each course for
hemoglobin ≤ 11 g/dL.
In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this
study within 18-20 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
Antonius A. Miller, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|Methodist Medical Center of Illinois||Peoria, Illinois 61636|
|Elliot Regional Cancer Center||Manchester, New Hampshire 03103|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|Veterans Affairs Medical Center - Baltimore||Baltimore, Maryland 21201|
|Veterans Affairs Medical Center - Dallas||Dallas, Texas 75216|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|Hematology Oncology Associates of the Quad Cities||Bettendorf, Iowa 52722|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|New Hampshire Oncology-Hematology, PA - Hooksett||Hooksett, New Hampshire 03106|
|Lenoir Memorial Cancer Center||Kinston, North Carolina 28503-1678|
|Zimmer Cancer Center at New Hanover Regional Medical Center||Wilmington, North Carolina 28402-9025|
|University of Illinois Cancer Center||Chicago, Illinois 60612-7243|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Parkland Memorial Hospital||Dallas, Texas 75235|
|Veterans Affairs Medical Center - Chicago Westside Hospital||Chicago, Illinois 60612|
|University Medical Center of Southern Nevada||Las Vegas, Nevada 89102|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees||Camden, New Jersey 08103|
|Beebe Medical Center||Lewes, Delaware 19958|
|St. Francis Hospital||Wilmington, Delaware 19805|
|St. Joseph Medical Center||Bloomington, Illinois 61701|
|Graham Hospital||Canton, Illinois 61520|
|Memorial Hospital||Carthage, Illinois 62321|
|Eureka Community Hospital||Eureka, Illinois 61530|
|Galesburg Cottage Hospital||Galesburg, Illinois 61401|
|Galesburg Clinic||Galesburg, Illinois 61401|
|Mason District Hospital||Havana, Illinois 62644|
|Hopedale Medical Complex||Hopedale, Illinois 61747|
|Kewanee Hospital||Kewanee, Illinois 61443|
|McDonough District Hospital||Macomb, Illinois 61455|
|BroMenn Regional Medical Center||Normal, Illinois 61761|
|Community Cancer Center||Normal, Illinois 61761|
|Community Hospital of Ottawa||Ottawa, Illinois 61350|
|Cancer Treatment Center at Pekin Hospital||Pekin, Illinois 61554|
|OSF St. Francis Medical Center||Peoria, Illinois 61637|
|Proctor Hospital||Peoria, Illinois 61614|
|Illinois Valley Community Hospital||Peru, Illinois 61354|
|Perry Memorial Hospital||Princeton, Illinois 61356|
|St. Margaret's Hospital||Spring Valley, Illinois 61362|
|Union Hospital Cancer Center at Union Hospital||Elkton MD, Maryland 21921|
|Creighton University Medical Center||Omaha, Nebraska 68131-2197|
|Charles R. Wood Cancer Center at Glens Falls Hospital||Glens Falls, New York 12801|
|Community General Hospital of Greater Syracuse||Syracuse, New York 13215|
|Oncology Hematology Associates of Central Illinois - Ottawa||Ottawa, Illinois 61350|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|Cancer Resource Center - Lincoln||Lincoln, Nebraska 68510|
|Cancer Care Associates - Mercy Campus||Oklahoma City, Oklahoma 73120|
|Methodist Cancer Center at Methodist Hospital - Omaha||Omaha, Nebraska 68114|
|Zale Lipshy University Hospital||Dallas, Texas 75235-7786|
|McLeod Regional Medical Center||Florence, South Carolina 29501|
|Arch Medical Services, Incorporated at Center for Cancer Care Research||Saint Louis, Missouri 63141|
|Lakes Region General Hospital||Laconia, New Hampshire 03246|
|Faxton Regional Cancer Center||Utica, New York 13502|
|El Camino Hospital||Mountain View, California 94040|
|St. Mary's Regional Cancer Center at St. Mary's Medical Center||Huntington, West Virginia 25702|