Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Anemia, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer
About this trial
This is an interventional treatment trial for Anemia focused on measuring drug/agent toxicity by tissue/organ, anemia, neutropenia, stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, adenosquamous cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes: Squamous carcinoma Basaloid carcinoma Adenocarcinoma Bronchoalveolar carcinoma Adenosquamous carcinoma Large cell carcinoma Large cell neuroendocrine carcinoma Giant cell carcinoma Sarcomatoid carcinoma Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection Stage IIIB disease due to malignant pleural effusion OR stage IV disease Measurable disease At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are considered nonmeasurable disease: Bone lesions Brain metastases or leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Brain metastases are allowed provided patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL AST ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ ULN Other Not pregnant or nursing Fertile patients must use effective contraception No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent growth factors Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy See Disease Characteristics No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic Radiotherapy See Disease Characteristics Prior radiotherapy allowed for brain metastases only No concurrent palliative radiotherapy Surgery See Disease Characteristics
Sites / Locations
- El Camino Hospital
- Beebe Medical Center
- CCOP - Christiana Care Health Services
- St. Francis Hospital
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- University of Illinois Cancer Center
- Veterans Affairs Medical Center - Chicago Westside Hospital
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Hematology Oncology Associates of the Quad Cities
- Holden Comprehensive Cancer Center at University of Iowa
- Greenebaum Cancer Center at University of Maryland Medical Center
- Veterans Affairs Medical Center - Baltimore
- Union Hospital Cancer Center at Union Hospital
- Arch Medical Services, Incorporated at Center for Cancer Care Research
- Missouri Baptist Cancer Center
- Cancer Resource Center - Lincoln
- Methodist Cancer Center at Methodist Hospital - Omaha
- Creighton University Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology-Hematology, PA - Hooksett
- Lakes Region General Hospital
- Elliot Regional Cancer Center
- Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
- Charles R. Wood Cancer Center at Glens Falls Hospital
- CCOP - Hematology-Oncology Associates of Central New York
- SUNY Upstate Medical University Hospital
- Community General Hospital of Greater Syracuse
- Faxton Regional Cancer Center
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- Lenoir Memorial Cancer Center
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Cancer Care Associates - Mercy Campus
- McLeod Regional Medical Center
- Veterans Affairs Medical Center - Dallas
- Parkland Memorial Hospital
- Zale Lipshy University Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Chemotherapy without BNP7787
Chemotherapy + BNP7787
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787