This study has been completed.
First Received: June 29, 2006 Last Updated: March 30, 2010 History of Changes
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.
Drug: NOV-002 Injection in combination with Carboplatin vs. Paclitaxel and Carboplatin
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
More Information
No publications provided
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
MFG
Chali