A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
PIONEER
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.
1 other identifier
interventional
600
11 countries
143
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2005
Shorter than P25 for phase_3
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedNovember 24, 2020
November 1, 2020
December 22, 2005
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to compare the overall survival of female patients randomized to CT-2103 to that of female patients randomized to paclitaxel.
Secondary Outcomes (1)
Secondary objectives are to compare the progression-free survival, response rate, disease control, clinical benefit, quality of life, and the safety and tolerability of the treatment arms.
Interventions
Eligibility Criteria
You may qualify if:
- Female.
- Histologically- or cytologically-confirmed diagnosis of NSCLC.
- ECOG performance score of 2.
- Patients who meet one of the following criteria:
- Stage IIIB who are not candidates for combined modality therapy (primary radiation therapy or surgery), or
- Stage IV.
- Age greater than or equal to 18 years.
- Adequate bone marrow function
- Adequate renal function
- Adequate hepatic function
- Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards.
- Patients who have had major surgery must be fully recovered from the surgery.
- Ability to comply with the visit schedule and assessments required by the protocol.
- For patients of reproductive potential, commitment to use adequate contraception.
- Signed approved informed consent, with understanding of study procedures.
- +1 more criteria
You may not qualify if:
- Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103).
- Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology.
- Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent.
- Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
- Grade 2 or greater neuropathy.
- Clinically significant active infection for which active therapy is underway.
- Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent.
- Unstable medical conditions including unstable angina or myocardial infarction within the past 6 months before randomization. Patients with evidence of cardiac conduction abnormalities are eligible if their cardiac status is stable.
- Pregnant women or nursing mothers.
- Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CTI BioPharmalead
Study Sites (143)
Desert Oasis Cancer Center
Casa Grande, Arizona, 85222, United States
Arizona Hematology Oncology
Tucson, Arizona, 85704, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Heritage Physician Group, Oncology
Hot Springs, Arkansas, 71913, United States
Pacific Cancer Medical Center, Inc
Anaheim, California, 92801, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
Hematology/Oncology Group of Fresno, Inc
Fresno, California, 93720, United States
Comprehensive Cancer Center-Research Office
Glendale, California, 91204, United States
Loma Linda University Cancer Institute
Loma Linda, California, 92354, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Medical Oncology Care Associates
Orange, California, 92868, United States
The Cancer Research and Prevention Center
Soquel, California, 95073, United States
Bethesda Research Center
Boynton Beach, Florida, 33435, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
Florida Wellcare
Inverness, Florida, 34452, United States
Cancer & Blood Disease Center
Lecanto, Florida, 34461, United States
Oncology-Hematology Associates of West Broward
Tamarac, Florida, 33321, United States
Hematology Oncology Speaclist
Tampa, Florida, 33607, United States
Joliet Oncology Hematology Associates, Ltd.
Joliet, Illinois, 60435, United States
Loyola University Health Systems
Maywood, Illinois, 60153, United States
Mid-Illinois HEM & ONC Assoc.
Normal, Illinois, 61761, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Associated Physicians & Surgeons Clinic
Terre Haute, Indiana, 47804, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
West Kentucky Hematology & Oncology Group, PSC
Paducah, Kentucky, 42003, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
Unknown Facility
Troy, Michigan, 48085, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
St. Louis Cancer Care Center
Chesterfield, Missouri, 63017, United States
Columbia Comprehensive Cancer Care Clinics
Columbia, Missouri, 65201, United States
Bond Clinic
Rolla, Missouri, 65401, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Washington University Siteman Cancer Center Pharmacy
St Louis, Missouri, 63110, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Sierra Nevada Oncology Care
Carson City, Nevada, 89100, United States
Essex Oncology of North Jersey, PA
Belleville, New Jersey, 07109, United States
Atlanta HEM ONC
Manasquan, New Jersey, 08736, United States
Oncology and Hematology Specialist, PA
Mountain Lakes, New Jersey, 07046, United States
San Juan Oncology Association
Farmington, New Mexico, 87401, United States
Suny Downstate Medical Center
Brooklyn, New York, 11203, United States
Cancer Treatment Services
Corning, New York, 14830, United States
Interlakes Foundation, Inc.
Rochester, New York, 14623, United States
Guthrie Clinic
Sayre, New York, 18840, United States
Our Lady of Mercy Medical Center
The Bronx, New York, 10466, United States
New York Medical Collegw
Valhalla, New York, 10595, United States
Alamance Cancer Center
Burlington, North Carolina, 27215, United States
UNC Chapel Hill Oncology Protocol Office
Chapel Hill, North Carolina, 27599, United States
Leo Jenkins Cancer Center
Greenville, North Carolina, 28734, United States
Northwestern Carolina Oncology & Hematology
Hickory, North Carolina, 28602, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
University of Cleveland
Cleveland, Ohio, 44106, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Dayton Clinical Oncology Program
Dayton, Ohio, 45429, United States
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, 45042, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
The Family Cancer Center
Collierville, Tennessee, 38077, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
JPS Center for Cancer Care
Fort Worth, Texas, 76104, United States
Columbia Basin HEM/ONC
Kennewick, Washington, 99336, United States
Sanatorio Parque
Rosario, Santa Fe Province, S2000DSV, Argentina
CETEN
Beunos Aires, B1874ACL, Argentina
Hospital Privado de Comunidad
Buenos Aires, B7602CBM, Argentina
Hospital General de Agudos "Dr Teodoro Alvarez"
Buenos Aires, C1406FWY, Argentina
Instituto Alexander Fleming
Ciudad de Buenos Aires, C1426ANZ, Argentina
Instituto Oncologico de Cordoba - IONC
Córdoba, X5000AA1, Argentina
LUCEN
Cuidad Autonoma de Buenos Aires, C1405CUB, Argentina
ISIS Clinica Especializada
Urquiza, 3022, Argentina
District Oncology Dispensary
Plovdiv, 4000, Bulgaria
District Oncolodispensary with Impatient sector
Rousse, 7002, Bulgaria
Military Medical Academy
Sofia, 1606, Bulgaria
Regional Oncology Dispensary with Inpatient Secot-Sofia District
Sogia, 1233, Bulgaria
Regional Oncology Dispensary with Inpatient Sector
Varna, 9010, Bulgaria
University Mulitprofile Hospital for Active Treatment "Sveta Marina"
Varna, 9010, Bulgaria
University Multiprofile Hospital for Active Treatment "Sveta Marina"
Varna, 9010, Bulgaria
Regional Oncology Dispensary with Inpatient sector
Veliko Tarnovo, 5000, Bulgaria
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Erzsebet Juhasz
Budapest, 1529, Hungary
University of Debrecen, Pulmonology Clinic
Debreen, 4032, Hungary
Hospital for Thoracic Diseases of Csongrad Country
Deszk, 6772, Hungary
Pulmonology Institute of Veszprem County
Farkasgyepű, 8582, Hungary
Hospital for Pulmonological Diseases of the Bekes County
Gyula, 5703, Hungary
Hospital of the Chest Desease of the Hungarian Reformed Church
Mosdós, 7257, Hungary
Karolina Hospital
Mosonmagyaróvár, 9200, Hungary
Barany County Hospital
Pécs, 7623, Hungary
Erzsebet Hospital
Sopron, 9400, Hungary
Sanatorium for Pulmonological Diseases
Törökbálint, 2045, Hungary
Centenario Hospital Miguel Hidalgo
Aguascalientes, Aguascalientes, 20230, Mexico
CIMA Chihuahua
Chihuahua City, Chih, 31238, Mexico
Hospital General
Durango, Durango, 34079, Mexico
Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega"
Acapulco de Juárez, Guerrero, 39570, Mexico
Hospital Dr. Angel Leano
Zapopan, Jalisco, 45200, Mexico
Hospital Star Medica Morelina
Morelia, Michoacán, 58070, Mexico
Monterrey International Research Center
Monterrey, N.L., 64020, Mexico
Centro Estatal de Canceologia
Jalapa, Veracruz, 31238, Mexico
Centro Anticanceroso de la Cruz Roja Mexicana de Merida
Mérida, Yucatán, 9700, Mexico
Centro Estatal de Cancerologia
Chihuahua City, 31000, Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, 78240, Mexico
Hospital General Regional
Veracruz, 91700, Mexico
Kujawsko-Pomorskie Centrum Pulmunologii
Bydgoszcz, 85-326, Poland
Krakowski Szpital Specjelistyczny
Kawkow, 31-202, Poland
Centrum Onkologii Ziemii Lubelskiej
Lublin, 20-090, Poland
Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji
Olsztyn, 10-228, Poland
Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy
Otwock, 05-400, Poland
Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ
Poznan, 60-569, Poland
SPSK nr l im. Przemienienia AM w Poznaniu
Poznan, 61-848, Poland
MSc Grezegorz Jedrejezak
Wroclaw, 50-891, Poland
Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105
Wroclaw, 53-439, Poland
Institutul Oncologie - Clinic de Oncologie Medicala
Bucharest, 022328, Romania
Prof. Dr. Al. Trestioreanu Institute of Oncology
Bucharest, 022328, Romania
"Prof. Dr. I. Chiricuta" Institute of Oncology
Cluj-Napoca, 400015, Romania
Emergency Clinical County Hospital
Craiova, 200642, Romania
Oradea Clinical County Hospital
Oradea, 410032, Romania
Clinical County Hospital
Sibiu, 550245, Romania
Timisoara Emergency Clinical Municipal Hospital
Timișoara, 300223, Romania
Chelyabinsk Regional Oncology Center
Chelyabinsk, 454087, Russia
Krasnodar City Oncology Center
Krasnodar, 350040, Russia
Moscow Oncology Clinical Dispensary #1
Moscow, 109033, Russia
SI Russian Oncological Scientific Center after N.N. Blokhim RAMS
Moscow, 115478, Russia
SI Russian Oncological Scientific Center after N.N. Blokhin RAMS
Moscow, 115478, Russia
Centeral ClinicalHospital of the President o the Russian Federation
Moscow, 121356, Russia
Moscow Municpal Oncology Hospital #62
Moscow Region, 143423, Russia
Omsk Regional Oncology Center
Omsk, 644013, Russia
Orenburg Regional Oncology Clinical Center
Orenburg, 460021, Russia
Lenigrad Regional Oncology Center
Saint Petersburg, 191104, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
St. Petersbrug State Medical Pavlov University
Saint Petersburg, 197089, Russia
St. Petersburg City Clinical Oncology Center
Saint Petersburg, 198255, Russia
Donetsk Regional Antineoplastic Center
Donetsk, 83092, Ukraine
Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University
Ivano-Frankivsk, 76018, Ukraine
Instiute of Oncology under AMS of Ukraine
Kiev, 3022, Ukraine
Volyn Regional Oncology Dispensary
Lutsk, 43018, Ukraine
Uzhgorod National University, Regional Clinical Oncology Dispensary
Uzhhorod, 88014, Ukraine
Vinnitsa State Medical University
Vynnytsya, 21029, Ukraine
Zaporizhzhya Regional Oncology Dispensary
Zaprizhzhya, 69040, Ukraine
The Royal Bournemouth Hospital
Bournemouth, BH77DW, United Kingdom
Oncology Pharmacy
London, SE19RT, United Kingdom
Wythenshaw Hospital, Pharmacy Department
Manchester, M23 9LT, United Kingdom
Southhampton General Hospital
Southhampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
December 1, 2005
Study Completion
December 1, 2006
Last Updated
November 24, 2020
Record last verified: 2020-11