Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of non-small lung cancer (NSCLC) Stage IIIB (malignant pleural/pericardial effusion) or IV Relapsed or refractory disease Measurable disease that has not been irradiated Previously treated with 1, and only 1, cytotoxic chemotherapy regimen in the neoadjuvant, adjuvant, or metastatic setting No untreated or symptomatic brain metastases or leptomeningeal disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 (without growth factor support) Platelet count at least 100,000/mm^3 No bleeding or coagulation disorder Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and AST no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Albumin at least 3.0 g/dL PT no greater than 1.5 times ULN OR INR no greater than 1.3 PTT no greater than 1.5 times ULN No chronic hepatitis No chronic cirrhosis Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled congestive heart failure Pulmonary: No severe pulmonary disease No requirement for oxygen due to pneumonectomy No severe pleural effusion secondary to NSCLC Immunologic: HIV negative No active infection No active autoimmune disease Other: No other concurrent active cancer No uncontrolled diabetes mellitus No uncontrolled seizure disorder No peripheral neuropathy grade 2 or greater No active peptic ulcer disease No other significant medical disease No intellectual, emotional, or physical disability that would preclude study participation No neurologic disorders, overt psychosis, mental disability, or evidence of a limited capacity to give informed consent or to comply with study treatment No known hypersensitivity to phosphorothioate-containing oligonucleotides No history of hypersensitivity to drugs containing the excipient Tween 80 (polysorbate 80) Satisfactory venous access for multi-day continuous infusion Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior cytokines or vaccine therapy for NSCLC At least 3 weeks since prior immunotherapy or biologic therapy for NSCLC No concurrent anticancer biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for NSCLC No prior docetaxel No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent corticosteroids* except for the following conditions: CNS disease Underlying lung disease NOTE: *Dose must be stable or decreasing for at least 4 weeks before study participation Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for NSCLC No prior radiotherapy to 25% or more of bone marrow (e.g., whole pelvis) No concurrent anticancer radiotherapy Surgery: At least 3 weeks since prior surgery for NSCLC No prior organ allograft Other: Recovered from prior therapy Prior first-line epidermal growth factor receptors (EGFR) administered with cytotoxic therapy are allowed At least 3 weeks since prior investigational drugs At least 3 weeks since other prior therapy NSCLC No prior anticancer therapy subsequent to the first (and only) prior cytotoxic chemotherapy regimen No prior second-line EGFR therapy No prior oblimersen (G3139) No other concurrent investigational or anticancer therapies No concurrent anticoagulation therapy except for warfarin (1 mg/day) for central line prophylaxis
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Montgomery Cancer Center
- Little Rock Hematology-Oncology Associates
- East Bay Medical Oncology
- Jonsson Comprehensive Cancer Center, UCLA
- Medical Oncology Care Associates
- Pacific Hematology/Oncology
- John Wayne Cancer Institute at Saint John's Health Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Whittingham Cancer Center
- Lakeland Regional Cancer Center
- Georgia Cancer Specialists - Northside Office
- Augusta Oncology Associates
- University of Chicago Cancer Research Center
- CCOP - Northern Indiana CR Consortium
- Central Baptist Hospital
- Hematology Oncology Services
- Louisiana State University Health Sciences Center - Shreveport
- Josephine Ford Cancer Center at Henry Ford Hospital
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
- Summit Medical Group, P.A.
- Winthrop University Hospital
- North General Hospital
- Veterans Affairs Medical Center - Oklahoma City
- Charleston Cancer Center
- Arlington Cancer Center
- Medical City Dallas Hospital
- Harold Simmons Cancer Center
- University of Texas - MD Anderson Cancer Center
- Joe Arrington Cancer Research and Treatment Center
- Texas Cancer Care
- Madigan Army Medical Center
- Yakima Regional Cancer Care Center
- Morgantown Internal Medicine Group
- West Virginia University Hospitals
- Princess Margaret Hospital
- Hopital Charles Lemoyne
- McGill University
- L'Hopital Laval
- Medical Radiological Research Center RAMS
- Russian Academy of Medical Sciences Cancer Research Center
- P.A. Hertzen Research Oncology Institute
- Municipal Oncological Dispensary
- Petrov Research Institute of Oncology