903
Participants
Start Date
November 30, 2006
Primary Completion Date
January 31, 2010
Study Completion Date
February 28, 2010
Paclitaxel
"Paclitaxel is dosed at 200 mg/m2, as a 3 hour infusion.~All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first."
NOV-002
"* Two 60 mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one~* For each nominal 21-day paclitaxel and carboplatin cycle:~ * 60 mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin~ * followed by 60 mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins~Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first."
Carboplatin
"Carboplatin is dosed at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing.~All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first.~The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel, as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing."
Clinical Hospital Center Bezanijska kosa, Belgrade
Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center, Chernihiv
"Clinical Center Nis, Clinic for Lung Diseases Knez Selo", Niš
Cherkasy Regional Oncology Center, Cherkassy
Thomas Jefferson University Hospital, Philadelphia
Institute of Lung Diseases Sremka Kamenica, Kamenitz
St. Agnes Hospital, Baltimore
Sondrio Hospital, Sondrio
Azienda Ospedaliera Treviglio Caravaggio, Bergamo
Lin Clinic, Haifa
Northwest Alabama Cancer Center, Muscle Shoals
Cleveland Clinic Foundation Taussig Cancer Center, Cleveland
Meir Medical Center, Kfar Saba
Northern Indiana Cancer Research Consortium, South Bend
Institute of Oncology, Petah Tikva
City General Hospital #4, Dnipropetrovsk
Azienda Ospedaliera Careggi, Florence
Sheba Medical Center, Ramat Gan
Park Nicollet Clinic - Cancer Center St. Louis Park, Saint Louis Park
University of Minnesota Medical Center, Fairview, Minneapolis
University of Chicago Medical Center, Chicago
S.P. Grigoryev Institute of Medical Radiology, Kharkiv
Assaf Harofeh Hospital, Ẕerifin
Regional Oncological Center, Ivano-Frankivsk
Barzilai Medical Center, Ashkelon
South Texas Institute of Cancer, Corpus Christi
Zakarpatsky Regional Oncological Clinical Center, Uzhhorod
Sharp Memorial Hospital, San Diego
Crimean Republican Clinical Oncology Center, Simferopol
Arkhangelsk Regional Clinical Oncology Center, Arkhangelsk
Leningrad Regional Clinical Hospital, Department of Thoracic Surgery, Saint Petersburg
City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery, Saint Petersburg
St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development, Saint Petersburg
City Clinical Oncology Center, Thoracic Department, Saint Petersburg
Craiova Emergency Clinical County Hospital, Craiova
S.C. Oncomed SRL, Timișoara
Oncology Center, Hematology Department, Sochi
Stavropol Regional Clinical Oncology Center, Chemotherapy Department, Stavropol
Stavropol Regional Clinical Oncology Center, Pyatigorsk
Tambov Regional Oncology Center, Chemotherapy Department, Tambov
Voronezh Regional Clinical Oncology Center, Voronezh
Institute of Oncology Cluj-Napoca, Cluj-Napoca
Institute of Oncology, Cluj-Napoca, Cluj-Napoca
Clinical Oncology Center, Chemotherapy Department, Kazan'
Kazan Oncology Center, Tatarstan
Chelyabinsk Regional Oncology Center, Chemotherapy Department, Chelyabinsk
Orenburg Regional Clinical Oncology Center, Orenburg
Omsk Regional Clinical Oncology Center, Omsk
Massachusetts General Hospital, Boston
Dartmouth Hitchcock Medical Center, Lebanon
William Osler Health Center, Brampton
Humber River Regional Hospital, Weston
Jewish General Hospital, Montreal
Laval Hospital, Sainte-Foy
Oddzial Pulmonologiczny z Pododdzialem Chemioterapii, Bystra
Samodzielny Publiczny Szpital Kliniczny N°.1, Gdansk
Oddzial Chemioterapii Pomorskie Centrum Onkologii,, Gdynia
Katedra Onkologii Akademii Medycznej w Lodzi, Lodz
Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA, Olsztyn
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III, Otwock
Wielkopolskie Centrum Chorob, Poznan
Oddzial Gruzlicy I Chorob Pluc I P, Prabuty
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie, Warsaw
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Warsaw
Institute of Oncology, Department of Medical Oncology II, Bucharest
Hospital Clinic i Provincial de Barcelona, Barcelona
Hospital Mutua de Terrassa, Terrassa
Kantonales Spital Sursee-Wolhusen, Sursee
Oncology Institute under the Ukrainian Academy of Medical Sciences, Kyiv
Anchor Unit, Aberdeen Royal Infirmary, Aberdeen
Ninewells Hospital and Medical School Department of Cancer Medicine, Dundee
St. Luke's Cancer Centre, Guildford
Oncology Research, Nottingham City Hospital, Nottingham
Dorset Cancer Centre, Poole Hospital, Poole
Yeovil District Hospital NHS Foundation Trust, Higher Kingston, Somerset
Lead Sponsor
Cellectar Biosciences, Inc.
INDUSTRY