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Sponsored by: |
Cell Therapeutics |
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Information provided by: | Cell Therapeutics |
ClinicalTrials.gov Identifier: | NCT00269828 |
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2. Study drug will be administered on day 1 of each 21 day cycle
Condition | Intervention | Phase |
---|---|---|
NSCLC |
Drug: paclitaxel Drug: paclitaxel poliglumex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Paclitaxel Poliglumex (CT-2103) vs. Paclitaxel for the Treatment of Women With Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) Who Are Performance Status 2. |
Estimated Enrollment: | 600 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2006 |
See Summary
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet one of the following criteria:
Exclusion Criteria:
United States, Arizona | |
Arizona Hematology Oncology | |
Tucson, Arizona, United States, 85704 | |
Desert Oasis Cancer Center | |
Casa Grande, Arizona, United States, 85222 | |
United States, Arkansas | |
Heritage Physician Group, Oncology | |
Hot Springs, Arkansas, United States, 71913 | |
Genesis Cancer Center | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Pacific Shores Medical Group | |
Long Beach, California, United States, 90813 | |
Comprehensive Cancer Center-Research Office | |
Glendale, California, United States, 91204 | |
Comprehensive Blood and Cancer Center | |
Bakersfield, California, United States, 93309 | |
Medical Oncology Care Associates | |
Orange, California, United States, 92868 | |
The Cancer Research and Prevention Center | |
Soquel, California, United States, 95073 | |
Loma Linda University Cancer Institute | |
Loma Linda, California, United States, 92354 | |
Pacific Cancer Medical Center, Inc | |
Anaheim, California, United States, 92801 | |
Hematology/Oncology Group of Fresno, Inc | |
Fresno, California, United States, 93720 | |
Providence St. Joseph Medical Center | |
Burbank, California, United States, 91505 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
United States, Florida | |
Bethesda Research Center | |
Boynton Beach, Florida, United States, 33435 | |
Oncology-Hematology Associates of West Broward | |
Tamarac, Florida, United States, 33321 | |
Florida Wellcare | |
Inverness, Florida, United States, 34452 | |
Cancer & Blood Disease Center | |
Lecanto, Florida, United States, 34461 | |
Hematology Oncology Speaclist | |
Tampa, Florida, United States, 33607 | |
Broward Oncology Associates | |
Ft. Lauderdale, Florida, United States, 33308 | |
United States, Illinois | |
Mid-Illinois HEM & ONC Assoc. | |
Normal, Illinois, United States, 61761 | |
Joliet Oncology Hematology Associates, Ltd. | |
Joliet, Illinois, United States, 60435 | |
Loyola University Health Systems | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
Associated Physicians & Surgeons Clinic | |
Terre Haute, Indiana, United States, 47804 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
United States, Kentucky | |
West Kentucky Hematology & Oncology Group, PSC | |
Paducah, Kentucky, United States, 42003 | |
Kentucky Cancer Clinic | |
Hazard, Kentucky, United States, 41701 | |
United States, Louisiana | |
Cabrini Center for Cancer Care | |
Alexandria, Louisiana, United States, 71301 | |
United States, Michigan | |
West Michigan Cancer Center | |
Kalamazoo, Michigan, United States, 49007 | |
Oncology Care Associates, PLLC | |
St. Joseph, Michigan, United States, 49085 | |
Troy, Michigan, United States, 48085 | |
United States, Minnesota | |
Hubert H. Humphrey Cancer Center | |
Robbinsdale, Minnesota, United States, 55422 | |
United States, Missouri | |
Bond Clinic | |
Rolla, Missouri, United States, 65401 | |
St. Louis Cancer Care Center | |
Chesterfield, Missouri, United States, 63017 | |
Saint Louis University | |
St. Louis, Missouri, United States, 63110 | |
Columbia Comprehensive Cancer Care Clinics | |
Columbia, Missouri, United States, 65201 | |
Washington University Siteman Cancer Center Pharmacy | |
St. Louis, Missouri, United States, 63110 | |
United States, Montana | |
Montana Cancer Specialists | |
Missoula, Montana, United States, 59802 | |
United States, Nevada | |
Sierra Nevada Oncology Care | |
Carson City, Nevada, United States, 89100 | |
United States, New Jersey | |
Atlanta HEM ONC | |
Manasquan, New Jersey, United States, 08736 | |
Essex Oncology of North Jersey, PA | |
Belleville, New Jersey, United States, 07109 | |
Oncology and Hematology Specialist, PA | |
Moutain Lakes, New Jersey, United States, 07046 | |
United States, New Mexico | |
San Juan Oncology Association | |
Farmington, New Mexico, United States, 87401 | |
United States, New York | |
Interlakes Foundation, Inc. | |
Rochester, New York, United States, 14623 | |
New York Medical Collegw | |
Valhalla, New York, United States, 10595 | |
Suny Downstate Medical Center | |
Brooklyn, New York, United States, 11203 | |
Our Lady of Mercy Medical Center | |
Bronx, New York, United States, 10466 | |
Cancer Treatment Services | |
Corning, New York, United States, 14830 | |
Guthrie Clinic | |
Sayre, New York, United States, 18840 | |
United States, North Carolina | |
UNC Chapel Hill Oncology Protocol Office | |
Chapel Hill, North Carolina, United States, 27599 | |
Alamance Cancer Center | |
Burling, North Carolina, United States, 27215 | |
Leo Jenkins Cancer Center | |
Greenville, North Carolina, United States, 28734 | |
Northwestern Carolina Oncology & Hematology | |
Hickory, North Carolina, United States, 28602 | |
United States, North Dakota | |
St. Alexius Medical Center | |
Bismark, North Dakota, United States, 58501 | |
United States, Ohio | |
Signal Point Hematology/Oncology, Inc. | |
Middletown, Ohio, United States, 45042 | |
Dayton Clinical Oncology Program | |
Dayton, Ohio, United States, 45429 | |
The Cleveland Clinic Foundation, Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
University of Cleveland | |
Cleveland, Ohio, United States, 44106 | |
Metro Health Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, South Carolina | |
Charleston Hematology Oncology | |
Charleston, South Carolina, United States, 29403 | |
United States, Tennessee | |
The Family Cancer Center | |
Collierville, Tennessee, United States, 38077 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75201 | |
JPS Center for Cancer Care | |
Ft. Worth, Texas, United States, 76104 | |
United States, Washington | |
Columbia Basin HEM/ONC | |
Kennewick, Washington, United States, 99336 | |
Argentina | |
Hospital General de Agudos "Dr Teodoro Alvarez" | |
Buenos Aires, Argentina, C1406FWY | |
CETEN | |
Beunos Aires, Argentina, B1874ACL | |
ISIS Clinica Especializada | |
Urquiza, Argentina, 3022 | |
Hospital Privado de Comunidad | |
Buenos Aires, Argentina, B7602CBM | |
LUCEN | |
Cuidad Autonoma de Buenos Aires, Argentina, C1405CUB | |
Instituto Oncologico de Cordoba - IONC | |
Cordoba, Argentina, X5000AA1 | |
Instituto Alexander Fleming | |
Ciudad de Buenos Aires, Argentina, C1426ANZ | |
Argentina, Santa Fe | |
Sanatorio Parque | |
Rosario, Santa Fe, Argentina, S2000DSV | |
Bulgaria | |
District Oncolodispensary with Impatient sector | |
Rousse, Bulgaria, 7002 | |
Regional Oncology Dispensary with Inpatient sector | |
Veliko Tarnovo, Bulgaria, 5000 | |
Regional Oncology Dispensary with Inpatient Sector | |
Varna, Bulgaria, 9010 | |
District Oncology Dispensary | |
Plovdiv, Bulgaria, 4000 | |
Military Medical Academy | |
Sofia, Bulgaria, 1606 | |
Regional Oncology Dispensary with Inpatient Secot-Sofia District | |
Sogia, Bulgaria, 1233 | |
University Mulitprofile Hospital for Active Treatment "Sveta Marina" | |
Varna, Bulgaria, 9010 | |
University Multiprofile Hospital for Active Treatment "Sveta Marina" | |
Varna, Bulgaria, 9010 | |
Canada, Quebec | |
Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 | |
Hungary | |
Hospital of the Chest Desease of the Hungarian Reformed Church | |
Mosdos, Hungary, 7257 | |
Pulmonology Institute of Veszprem County | |
Farkasgyepu, Hungary, 8582 | |
Sanatorium for Pulmonological Diseases | |
Torokbalint, Hungary, 2045 | |
Karolina Hospital | |
Mosonmagyarovar, Hungary, 9200 | |
Hospital for Pulmonological Diseases of the Bekes County | |
Gyula, Hungary, 5703 | |
Erzsebet Juhasz | |
Budapest, Hungary, 1529 | |
Erzsebet Hospital | |
Sopron, Hungary, 9400 | |
Hospital for Thoracic Diseases of Csongrad Country | |
Deszk, Hungary, 6772 | |
Barany County Hospital | |
Pecs, Hungary, 7623 | |
University of Debrecen, Pulmonology Clinic | |
Debreen, Hungary, 4032 | |
Mexico | |
Hospital Central "Dr. Ignacio Morones Prieto" | |
San Luis Potosi, Mexico, 78240 | |
Centro Estatal de Cancerologia | |
Chihuahua, Mexico, 31000 | |
Hospital General Regional | |
Veracruz, Mexico, 91700 | |
Mexico, Ags. | |
Centenario Hospital Miguel Hidalgo | |
Aguascalientes, Ags., Mexico, 20230 | |
Mexico, Chih | |
CIMA Chihuahua | |
Chihuahua, Chih, Mexico, 31238 | |
Mexico, Dgo. | |
Hospital General | |
Durango, Dgo., Mexico, 34079 | |
Mexico, Gro | |
Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega" | |
Acapulco, Gro, Mexico, 39570 | |
Mexico, Jalisco | |
Hospital Dr. Angel Leano | |
Zapopan, Jalisco, Mexico, 45200 | |
Mexico, Michoacan | |
Hospital Star Medica Morelina | |
Morelia, Michoacan, Mexico, 58070 | |
Mexico, N.L. | |
Monterrey International Research Center | |
Monterrey, N.L., Mexico, 64020 | |
Mexico, Veracruz | |
Centro Estatal de Canceologia | |
Jalapa, Veracruz, Mexico, 31238 | |
Mexico, Yucatan | |
Centro Anticanceroso de la Cruz Roja Mexicana de Merida | |
Merida, Yucatan, Mexico, 9700 | |
Poland | |
Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji | |
Olsztyn, Poland, 10-228 | |
MSc Grezegorz Jedrejezak | |
Wroclaw, Poland, 50-891 | |
Centrum Onkologii Ziemii Lubelskiej | |
Lublin, Poland, 20-090 | |
Kujawsko-Pomorskie Centrum Pulmunologii | |
Bydgoszcz, Poland, 85-326 | |
Krakowski Szpital Specjelistyczny | |
Kawkow, Poland, 31-202 | |
Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy | |
Otwock, Poland, 05-400 | |
Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ | |
Poznan, Poland, 60-569 | |
SPSK nr l im. Przemienienia AM w Poznaniu | |
Poznan, Poland, 61-848 | |
Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105 | |
Wroclaw, Poland, 53-439 | |
Romania | |
"Prof. Dr. I. Chiricuta" Institute of Oncology | |
Cluj-Napoca, Romania, 400015 | |
Clinical County Hospital | |
Sibiu, Romania, 550245 | |
Emergency Clinical County Hospital | |
Craiova, Romania, 200642 | |
Prof. Dr. Al. Trestioreanu Institute of Oncology | |
Bucharest, Romania, 022328 | |
Oradea Clinical County Hospital | |
Oradea, Romania, 410032 | |
Timisoara Emergency Clinical Municipal Hospital | |
Timisoara, Romania, 300223 | |
Institutul Oncologie - Clinic de Oncologie Medicala | |
Bucharest, Romania, 022328 | |
Russian Federation | |
Orenburg Regional Oncology Clinical Center | |
Orenburg, Russian Federation, 460021 | |
Moscow Oncology Clinical Dispensary #1 | |
Moscow, Russian Federation, 109033 | |
Moscow Municpal Oncology Hospital #62 | |
Moscow Region, Russian Federation, 143423 | |
Omsk Regional Oncology Center | |
Omsk, Russian Federation, 644013 | |
Lenigrad Regional Oncology Center | |
St. Petersburg, Russian Federation, 191104 | |
Leningrad Regional Clinical Hospital | |
St. Petersburg, Russian Federation, 194291 | |
Chelyabinsk Regional Oncology Center | |
Chelyabinsk, Russian Federation, 454087 | |
St. Petersburg City Clinical Oncology Center | |
Saint Petersburg, Russian Federation, 198255 | |
Krasnodar City Oncology Center | |
Krasnodar, Russian Federation, 350040 | |
SI Russian Oncological Scientific Center after N.N. Blokhim RAMS | |
Moscow, Russian Federation, 115478 | |
SI Russian Oncological Scientific Center after N.N. Blokhin RAMS | |
Moscow, Russian Federation, 115478 | |
Centeral ClinicalHospital of the President o the Russian Federation | |
Moscow, Russian Federation, 121356 | |
St. Petersbrug State Medical Pavlov University | |
St. Petersburg, Russian Federation, 197089 | |
Ukraine | |
Uzhgorod National University, Regional Clinical Oncology Dispensary | |
Uzhgorod, Ukraine, 88014 | |
Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University | |
Ivano-Frankovsk, Ukraine, 76018 | |
Zaporizhzhya Regional Oncology Dispensary | |
Zaprizhzhya, Ukraine, 69040 | |
Instiute of Oncology under AMS of Ukraine | |
Kiev, Ukraine, 3022 | |
Donetsk Regional Antineoplastic Center | |
Donetsk, Ukraine, 83092 | |
Vinnitsa State Medical University | |
Vynnytsya, Ukraine, 21029 | |
Volyn Regional Oncology Dispensary | |
Lutsk, Ukraine, 43018 | |
United Kingdom | |
Oncology Pharmacy | |
London, United Kingdom, SE19RT | |
Southhampton General Hospital | |
Southhampton, United Kingdom, SO16 6YD | |
The Royal Bournemouth Hospital | |
Bournemouth, United Kingdom, BH77DW | |
Wythenshaw Hospital, Pharmacy Department | |
Manchester, United Kingdom, M23 9LT |
Study ID Numbers: | PGT305, PIONEER |
Study First Received: | December 22, 2005 |
Last Updated: | February 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00269828 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-small cell lung cancer NSCLC PS 2 female chemotherapy |
Thoracic Neoplasms Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Tubulin Modulators |
Non-small Cell Lung Cancer Antimitotic Agents Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |