Paclitaxel + Carboplatin With/ut BMS-275291 in Advanced or Metastatic Non-small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC) Local or metastatic failure after surgery and/or radiotherapy allowed Phase II only: At least one measurable lesion At least 20 mm by conventional techniques OR 10 mm by spiral CT scan No known CNS metastases unless asymptomatic and at least 4 weeks since prior corticosteroid therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 2 times ULN (5 times ULN for liver metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure, unstable angina, congestive heart failure, second or third degree atrioventricular conduction defects, or ventricular arrhythmias requiring medication No myocardial infarction within the past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction to drugs containing Cremophor EL No serious active infection or other underlying medical condition that would preclude study participation No peripheral neuropathy No condition (e.g., psychological, geographical) that would preclude study participation No prior breast cancer or melanoma No other prior malignancy within the past 5 years except carcinoma in situ, basal cell or squamous cell skin cancer, or other cancer that has been curatively treated surgically PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No prior biological response modifiers No other concurrent biologic therapy or immunotherapy Chemotherapy: No prior antineoplastic chemotherapy, including intrapleural chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to study lesion (unless evidence of disease progression) or to 30% or greater of marrow bearing bones At least 1 week since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior major surgery No concurrent surgery Other: At least 2 weeks since prior investigational drugs No other concurrent cytotoxic anticancer therapy No other investigational drugs during and for 30 days after study
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of Arkansas for Medical Sciences
- Scripps Clinic
- Central Georgia Hematology Oncology, P.C.
- Queen's Medical Center
- Carle Cancer Center
- Lahey Clinic - Burlington
- Creighton University Cancer Center
- Duke University Medical Center
- University of Oklahoma Health Sciences Center
- Erlanger Health Systems
- Memorial Hospital Cancer Center - Chattanooga
- Williamson Medical Center
- Jackson-Madison County General Hospital
- Baptist Regional Cancer Center - Knoxville
- Saint Thomas Hospital
- Meharry Medical College
- Division of Medical Oncology - Vanderbilt
- AKH Vienna
- Allgemeines Krankenhaus der Stadt Wien
- Universiteit Gent
- Centre Hospitalier Regional de la Citadelle
- Algemeen Ziekenhuis Sint-Augustinus
- Cross Cancer Institute
- CancerCare Manitoba
- Nova Scotia Cancer Centre
- Royal Victoria Hospital, Barrie
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Ottawa Regional Cancer Centre
- Peterborough Oncology Clinic
- Algoma District Medical Group
- Hotel Dieu Health Sciences Hospital - Niagara
- Toronto Sunnybrook Regional Cancer Centre
- Mount Sinai Hospital - Toronto
- Toronto General Hospital
- Saint Joseph's Health Centre - Toronto
- Humber River Regional Hospital
- Cancer Care Ontario - Windsor Regional Cancer Centre
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Helsinki University Central Hospital
- CHR de Besancon - Hopital Jean Minjoz
- Hopital Avicenne
- CHR de Grenoble - La Tronche
- CRLCC Nantes - Atlantique
- Hopital de Neuhof
- Institut Claudius Regaud
- Centre Hospitalier Universitaire Bretonneau de Tours
- Stadisches Krankenhaus Martha Maria Halle-Dolau
- Allgemeines Krankenhaus
- Lungenklinik Hemer
- Marienhospital/Ruhr University Bochum
- Klinikum Rechts Der Isar/Technische Universitaet Muenchen
- Oncologia Medica - Perugia
- Ospedale San Filippo Neri
- Ospedale Carlo Forlanini
- Istituto Clinico Humanitas
- Ospedale Civile San Giovanni e Paolo
- Academisch Ziekenhuis Maastricht
- Medical University of Gdansk
- Centro Hospitalar de Vila Nova de Gaia
- Hospital Universitario 12 de Octubre
- Hospital Universitario Marques de Valdecilla
- Servicio De Oncologia
- Kantonspital Aarau
- Inselspital, Bern
- Universitaetsspital
- Charing Cross Hospital
- Chelsea Westminster Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BMS-275291
Placebo