Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer This study has been completed. First Received: June 29, 2006 Last Updated: March 30, 2010 History of Changes Sponsor: Novelos Therapeutics Information provided by: Novelos Therapeutics ClinicalTrials.gov Identifier: NCT00347412
Purpose The purpose of this clinical trial is to find out whether or not the combination of NOV-002 with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC).
Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination with chemotherapy had a better response (their tumors got smaller in one United States Phase 1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had a better survival rate than patients who did not receive NOV-002 with their chemotherapy.
Condition Intervention Phase Non Small Cell Lung Cancer Drug: Paclitaxel and Carboplatin Drug: NOV-002 Injection in combination with Carboplatin vs. Paclitaxel and Carboplatin Phase III
Study Type: Interventional Study Design: Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Phase 3 Trial, Randomized, Open-Label, of NOV-002 in Combination With Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Resource links provided by NLM:
MedlinePlus related topics: Cancer Lung Cancer Drug Information available for: Glutathione disulfide Paclitaxel Carboplatin U.S. FDA Resources
Further study details as provided by Novelos Therapeutics:
Primary Outcome Measures: Overall survival during the length of the trial, length of the trial is approximately two years after last patient in [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures: Improved progression-free survival (PFS) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Higher anti-tumor overall response rate (ORR) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
Immunomodulation as evidenced by changes in lymphocyte subsets [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 880 Study Start Date: November 2006 Study Completion Date: February 2010 Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions A: Experimental NOV-002 Injection in combination with Carboplatin and Paclitaxel Drug: NOV-002 Injection in combination with Carboplatin vs. Paclitaxel and Carboplatin NOV-002: (Group A only)
Two 60mg 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:
60mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin followed by 60mg 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. B: Active Comparator Paclitaxel and Carboplatin Alone Drug: Paclitaxel and Carboplatin Paclitaxel and carboplatin: (All randomized patients)
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. Locations:
United States, Alabama Northwest Alabama Cancer Center Muscle Shoals, Alabama, United States, 35661 United States, California Sharp Memorial Hospital San Diego, California, United States, 92123 United States, Illinois University of Chicago Medical Center Chicago, Illinois, United States, 60637 United States, Indiana Northern Indiana Cancer Research Consortium South Bend, Indiana, United States, 46601 United States, Maryland St. Agnes Hospital Baltimore, Maryland, United States, 21229 United States, Massachusetts Massachusetts General Hospital Boston, Massachusetts, United States, 02144 United States, Minnesota University of Minnesota Medical Center, Fairview Minneapolis, Minnesota, United States, 55455 Park Nicollet Clinic - Cancer Center St. Louis Park St. Louis Park, Minnesota, United States, 55416 United States, New Hampshire Dartmouth Hitchcock Medical Center Lebanon, New Hampshire, United States, 03756 United States, Ohio Cleveland Clinic Foundation Taussig Cancer Center Cleveland, Ohio, United States, 44195 United States, Pennsylvania Thomas Jefferson University Hospital Philadelphia, Pennsylvania, United States, 19107 United States, Texas South Texas Institute of Cancer Corpus Christi, Texas, United States, 78405 Canada, Ontario William Osler Health Center Brampton, Ontario, Canada, L6W 2Z8 Humber River Regional Hospital Weston, Ontario, Canada, M9N 1N8 Canada, Quebec Jewish General Hospital Montreal, Quebec, Canada, H3T1E2 Laval Hospital Sainte-Foy, Quebec, Canada, G1V 4G5 Israel Barzilai Medical Center Ashkelon, Israel, 78306 Lin Clinic Haifa, Israel, 31096 Meir Medical Center Kfar-Saba, Israel, 44281 Institute of Oncology Petach Tikva, Israel, 49100 Sheba Medical Center Ramat Gan, Israel, 52621 Assaf Harofeh Hospital Zerifin, Israel, 70300 Italy Azienda Ospedaliera Treviglio Caravaggio Bergamo, Italy, 24100 Azienda Ospedaliera Careggi Firenze, Italy, 50139 Sondrio Hospital Sondrio, Italy, 23100 Poland Oddzial Pulmonologiczny z Pododdzialem Chemioterapii Bystra, Poland, 43-360 Samodzielny Publiczny Szpital Kliniczny N°.1 Gdansk, Poland, 80-952 Oddzial Chemioterapii Pomorskie Centrum Onkologii, Gdynia, Poland, 81-519 Katedra Onkologii Akademii Medycznej w Lodzi Lodz, Poland, 93-513 Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA Olsztyn, Poland, 10-228 Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III Otwock, Poland, 05-400 Wielkopolskie Centrum Chorob Poznan, Poland, 60-659 Oddzial Gruzlicy I Chorob Pluc I P Prabuty, Poland, 82-550 Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie Warsaw, Poland, 02-781 Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Warszawa, Poland, 02-781 Romania, Timis County S.C. Oncomed SRL Timisoara, Timis County, Romania, 300239 Romania Institute of Oncology, Department of Medical Oncology II Bucharest, Romania, 022328 Institute of Oncology, Cluj-Napoca Cluj-Napoca, Romania, 400015 Institute of Oncology Cluj-Napoca Cluj-Napoca, Romania, 400015 Craiova Emergency Clinical County Hospital Craiova, Romania, 200642 Russian Federation Arkhangelsk Regional Clinical Oncology Center Arkhangelsk, Russian Federation, 163045 Chelyabinsk Regional Oncology Center, Chemotherapy Department Chelyabinsk, Russian Federation, 454087 Clinical Oncology Center, Chemotherapy Department Kazan, Russian Federation, 420029 Omsk Regional Clinical Oncology Center Omsk, Russian Federation, 644013 Orenburg Regional Clinical Oncology Center Orenburg, Russian Federation, 460021 Stavropol Regional Clinical Oncology Center Pyatigorsk, Russian Federation, 357500 Oncology Center, Hematology Department Sochi, Russian Federation, 354057 City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery St. Petersburg, Russian Federation, 194354 St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development St. Petersburg, Russian Federation, 197022 Leningrad Regional Clinical Hospital, Department of Thoracic Surgery St. Petersburg, Russian Federation, 194291 City Clinical Oncology Center, Thoracic Department St. Petersburg, Russian Federation, 198255 Stavropol Regional Clinical Oncology Center, Chemotherapy Department Stavropol, Russian Federation, 355047 Tambov Regional Oncology Center, Chemotherapy Department Tambov, Russian Federation, 390013 Kazan Oncology Center Tatarstan, Russian Federation, 420111 Voronezh Regional Clinical Oncology Center Voronezh, Russian Federation, 394000 Serbia Clinical Hospital Center Bezanijska kosa Belgrade, Serbia, 11080 Clinical Center Nis, Clinic for Lung Diseases "Knez Selo" Nis, Serbia, 18000 Institute of Lung Diseases Sremka Kamenica Sremska Kamenica, Serbia, 21204 Spain Hospital Clinic i Provincial de Barcelona Barcelona, Spain, 08036 Hospital Mutua de Terrassa Terrassa, Spain, 08221 Switzerland Kantonales Spital Sursee-Wolhusen Sursee, Switzerland, CH 6210 Ukraine Cherkasy Regional Oncology Center Cherkassy, Ukraine, 18009 Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center Chernihiv, Ukraine, 14029 City General Hospital #4 Dnipropetrovsk, Ukraine, 49102 Regional Oncological Center Ivano-Frankivsk, Ukraine, 76014 S.P. Grigoryev Institute of Medical Radiology Kharkiv, Ukraine, 61024 Oncology Institute under the Ukrainian Academy of Medical Sciences Kyiv, Ukraine, 03022 Crimean Republican Clinical Oncology Center Simferopol, Ukraine, 95023 Zakarpatsky Regional Oncological Clinical Center Uzhorod, Ukraine, 88014 United Kingdom, Scotland Anchor Unit, Aberdeen Royal Infirmary Aberdeen, Scotland, United Kingdom, AB25 2ZN Ninewells Hospital and Medical School Department of Cancer Medicine Dundee, Scotland, United Kingdom, DD1 9SY United Kingdom, Surrey St. Luke's Cancer Centre Guildford, Surrey, United Kingdom, GU2 7XX United Kingdom Oncology Research, Nottingham City Hospital Nottingham, United Kingdom, NG51PB Dorset Cancer Centre, Poole Hospital Poole, United Kingdom, BH152JB Yeovil District Hospital NHS Foundation Trust, Higher Kingston Somerset, United Kingdom, BA214AT
Sponsors and Collaborators Novelos Therapeutics Investigators Study Chair: Thomas Lynch, MD Massachusetts General Hospital Study Chair: Panos Fidias, MD Massachusetts General Hospital
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Responsible Party: Novelos Therapeutics, Inc ( Kim Hawkins ) ClinicalTrials.gov Identifier: NCT00347412 History of Changes Other Study ID Numbers: NOV002-C301 Study First Received: June 29, 2006 Last Updated: March 30, 2010 Health Authority: United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Swisterland: Swissmedic; Poland: Ministry of Health; Isreal: Ministry of Health; Italy: Italian Medicines Agency; Spain: Ministry of Health; Canada: Health Canada; Russia: Pharmacological Comitte, Ministry of Health
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