Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- AnemiaDrug/Agent Toxicity by Tissue/OrganLung CancerNeutropenia
- Interventions
- Registration Number
- NCT00077311
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* 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 dimesna.
* 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.
Secondary
* 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 treatment arms.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy without BNP7787 docetaxel Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC Chemotherapy + BNP7787 BNP7787 Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 Chemotherapy + BNP7787 darbepoetin alfa Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 Chemotherapy + BNP7787 pegfilgrastim Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 Chemotherapy + BNP7787 cisplatin Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 Chemotherapy without BNP7787 darbepoetin alfa Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC Chemotherapy without BNP7787 pegfilgrastim Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC Chemotherapy + BNP7787 docetaxel Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787 Chemotherapy without BNP7787 cisplatin Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
- Primary Outcome Measures
Name Time Method Toxicity 12 weeks Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity
- Secondary Outcome Measures
Name Time Method Survival q 6 mon for 2 yrs after registration, then annually Response during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs
Trial Locations
- Locations (64)
Graham Hospital
🇺🇸Canton, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
🇺🇸Baltimore, Maryland, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸Syracuse, New York, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Union Hospital Cancer Center at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Lakes Region General Hospital
🇺🇸Laconia, New Hampshire, United States
Arch Medical Services, Incorporated at Center for Cancer Care Research
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
Faxton Regional Cancer Center
🇺🇸Utica, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Voorhees, New Jersey, United States
Community General Hospital of Greater Syracuse
🇺🇸Syracuse, New York, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Cancer Care Associates - Mercy Campus
🇺🇸Oklahoma City, Oklahoma, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States