A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
- Conditions
- NSCLC
- Registration Number
- NCT00269828
- Lead Sponsor
- CTI BioPharma
- 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
- Detailed Description
See Summary
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 600
-
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.
-
Agreement to begin study therapy within 8 calendar days after randomization.
- 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.
- Evidence of significant unstable neurological symptoms within the 4 weeks before study randomization. (If unstable neurologic symptoms resulted from brain metastases, patient must meet inclusion criteria number 9).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (142)
Hospital General de Agudos "Dr Teodoro Alvarez"
🇦🇷Buenos Aires, Argentina
LUCEN
🇦🇷Cuidad Autonoma de Buenos Aires, Argentina
ISIS Clinica Especializada
🇦🇷Urquiza, Argentina
Regional Oncology Dispensary with Inpatient sector
🇧🇬Veliko Tarnovo, Bulgaria
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
University of Debrecen, Pulmonology Clinic
🇭🇺Debreen, Hungary
Arizona Hematology Oncology
🇺🇸Tucson, Arizona, United States
District Oncology Dispensary
🇧🇬Plovdiv, Bulgaria
Columbia Basin HEM/ONC
🇺🇸Kennewick, Washington, United States
CETEN
🇦🇷Beunos Aires, Argentina
Regional Oncology Dispensary with Inpatient Secot-Sofia District
🇧🇬Sogia, Bulgaria
Oncology Pharmacy
🇬🇧London, United Kingdom
Sanatorio Parque
🇦🇷Rosario, Santa Fe, Argentina
Instituto Alexander Fleming
🇦🇷Ciudad de Buenos Aires, Argentina
JPS Center for Cancer Care
🇺🇸Fort Worth, Texas, United States
Erzsebet Hospital
🇭🇺Sopron, Hungary
Wythenshaw Hospital, Pharmacy Department
🇬🇧Manchester, United Kingdom
CIMA Chihuahua
🇲🇽Chihuahua, Chih, Mexico
Hospital General
🇲🇽Durango, Dgo., Mexico
Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega"
🇲🇽Acapulco, Gro, Mexico
Chelyabinsk Regional Oncology Center
🇷🇺Chelyabinsk, Russian Federation
Krasnodar City Oncology Center
🇷🇺Krasnodar, Russian Federation
The Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Southhampton General Hospital
🇬🇧Southhampton, United Kingdom
Zaporizhzhya Regional Oncology Dispensary
🇺🇦Zaprizhzhya, Ukraine
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
West Kentucky Hematology & Oncology Group, PSC
🇺🇸Paducah, Kentucky, United States
New York Medical Collegw
🇺🇸Valhalla, New York, United States
University of Cleveland
🇺🇸Cleveland, Ohio, United States
The Cleveland Clinic Foundation, Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Pacific Cancer Medical Center, Inc
🇺🇸Anaheim, California, United States
Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Hematology/Oncology Group of Fresno, Inc
🇺🇸Fresno, California, United States
Comprehensive Cancer Center-Research Office
🇺🇸Glendale, California, United States
Loma Linda University Cancer Institute
🇺🇸Loma Linda, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
The Cancer Research and Prevention Center
🇺🇸Soquel, California, United States
Bethesda Research Center
🇺🇸Boynton Beach, Florida, United States
Florida Wellcare
🇺🇸Inverness, Florida, United States
Broward Oncology Associates
🇺🇸Fort Lauderdale, Florida, United States
Oncology-Hematology Associates of West Broward
🇺🇸Tamarac, Florida, United States
Cancer & Blood Disease Center
🇺🇸Lecanto, Florida, United States
Joliet Oncology Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Loyola University Health Systems
🇺🇸Maywood, Illinois, United States
Mid-Illinois HEM & ONC Assoc.
🇺🇸Normal, Illinois, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Associated Physicians & Surgeons Clinic
🇺🇸Terre Haute, Indiana, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Oncology Care Associates, PLLC
🇺🇸Saint Joseph, Michigan, United States
St. Louis Cancer Care Center
🇺🇸Chesterfield, Missouri, United States
Columbia Comprehensive Cancer Care Clinics
🇺🇸Columbia, Missouri, United States
Bond Clinic
🇺🇸Rolla, Missouri, United States
Washington University Siteman Cancer Center Pharmacy
🇺🇸Saint Louis, Missouri, United States
Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
Suny Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Interlakes Foundation, Inc.
🇺🇸Rochester, New York, United States
UNC Chapel Hill Oncology Protocol Office
🇺🇸Chapel Hill, North Carolina, United States
Alamance Cancer Center
🇺🇸Burlington, North Carolina, United States
Leo Jenkins Cancer Center
🇺🇸Greenville, North Carolina, United States
Northwestern Carolina Oncology & Hematology
🇺🇸Hickory, North Carolina, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Metro Health Medical Center
🇺🇸Cleveland, Ohio, United States
Signal Point Hematology/Oncology, Inc.
🇺🇸Middletown, Ohio, United States
Centenario Hospital Miguel Hidalgo
🇲🇽Aguascalientes, Ags., Mexico
Hospital Star Medica Morelina
🇲🇽Morelia, Michoacan, Mexico
Hospital General Regional
🇲🇽Veracruz, Mexico
Kujawsko-Pomorskie Centrum Pulmunologii
🇵🇱Bydgoszcz, Poland
SPSK nr l im. Przemienienia AM w Poznaniu
🇵🇱Poznan, Poland
Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105
🇵🇱Wroclaw, Poland
Prof. Dr. Al. Trestioreanu Institute of Oncology
🇷🇴Bucharest, Romania
Emergency Clinical County Hospital
🇷🇴Craiova, Romania
Oradea Clinical County Hospital
🇷🇴Oradea, Romania
SI Russian Oncological Scientific Center after N.N. Blokhim RAMS
🇷🇺Moscow, Russian Federation
Volyn Regional Oncology Dispensary
🇺🇦Lutsk, Ukraine
Hospital for Thoracic Diseases of Csongrad Country
🇭🇺Deszk, Hungary
Pulmonology Institute of Veszprem County
🇭🇺Farkasgyepu, Hungary
Barany County Hospital
🇭🇺Pecs, Hungary
Hospital Central "Dr. Ignacio Morones Prieto"
🇲🇽San Luis Potosi, Mexico
MSc Grezegorz Jedrejezak
🇵🇱Wroclaw, Poland
"Prof. Dr. I. Chiricuta" Institute of Oncology
🇷🇴Cluj-Napoca, Romania
Moscow Municpal Oncology Hospital #62
🇷🇺Moscow Region, Russian Federation
Omsk Regional Oncology Center
🇷🇺Omsk, Russian Federation
Orenburg Regional Oncology Clinical Center
🇷🇺Orenburg, Russian Federation
Donetsk Regional Antineoplastic Center
🇺🇦Donetsk, Ukraine
University Mulitprofile Hospital for Active Treatment "Sveta Marina"
🇧🇬Varna, Bulgaria
Heritage Physician Group, Oncology
🇺🇸Hot Springs, Arkansas, United States
Essex Oncology of North Jersey, PA
🇺🇸Belleville, New Jersey, United States
Hospital of the Chest Desease of the Hungarian Reformed Church
🇭🇺Mosdos, Hungary
Karolina Hospital
🇭🇺Mosonmagyarovar, Hungary
Krakowski Szpital Specjelistyczny
🇵🇱Kawkow, Poland
Institutul Oncologie - Clinic de Oncologie Medicala
🇷🇴Bucharest, Romania
Timisoara Emergency Clinical Municipal Hospital
🇷🇴Timisoara, Romania
St. Petersbrug State Medical Pavlov University
🇷🇺St. Petersburg, Russian Federation
Uzhgorod National University, Regional Clinical Oncology Dispensary
🇺🇦Uzhgorod, Ukraine
Regional Oncology Dispensary with Inpatient Sector
🇧🇬Varna, Bulgaria
Montana Cancer Specialists
🇺🇸Missoula, Montana, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Erzsebet Juhasz
🇭🇺Budapest, Hungary
Centeral ClinicalHospital of the President o the Russian Federation
🇷🇺Moscow, Russian Federation
Atlanta HEM ONC
🇺🇸Manasquan, New Jersey, United States
Cabrini Center for Cancer Care
🇺🇸Alexandria, Louisiana, United States
Instituto Oncologico de Cordoba - IONC
🇦🇷Cordoba, Argentina
Hospital for Pulmonological Diseases of the Bekes County
🇭🇺Gyula, Hungary
Sanatorium for Pulmonological Diseases
🇭🇺Torokbalint, Hungary
Desert Oasis Cancer Center
🇺🇸Casa Grande, Arizona, United States
Oncology and Hematology Specialist, PA
🇺🇸Mountain Lakes, New Jersey, United States
Hospital Privado de Comunidad
🇦🇷Buenos Aires, Argentina
District Oncolodispensary with Impatient sector
🇧🇬Rousse, Bulgaria
Military Medical Academy
🇧🇬Sofia, Bulgaria
Centro Estatal de Cancerologia
🇲🇽Chihuahua, Mexico
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Centro Anticanceroso de la Cruz Roja Mexicana de Merida
🇲🇽Merida, Yucatan, Mexico
Instiute of Oncology under AMS of Ukraine
🇺🇦Kiev, Ukraine
Centrum Onkologii Ziemii Lubelskiej
🇵🇱Lublin, Poland
University Multiprofile Hospital for Active Treatment "Sveta Marina"
🇧🇬Varna, Bulgaria
Monterrey International Research Center
🇲🇽Monterrey, N.l., Mexico
Centro Estatal de Canceologia
🇲🇽Jalapa, Veracruz, Mexico
St. Petersburg City Clinical Oncology Center
🇷🇺Saint Petersburg, Russian Federation
Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University
🇺🇦Ivano-Frankovsk, Ukraine
Vinnitsa State Medical University
🇺🇦Vynnytsya, Ukraine
Moscow Oncology Clinical Dispensary #1
🇷🇺Moscow, Russian Federation
SI Russian Oncological Scientific Center after N.N. Blokhin RAMS
🇷🇺Moscow, Russian Federation
Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji
🇵🇱Olsztyn, Poland
Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy
🇵🇱Otwock, Poland
Clinical County Hospital
🇷🇴Sibiu, Romania
Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ
🇵🇱Poznan, Poland
Lenigrad Regional Oncology Center
🇷🇺St. Petersburg, Russian Federation
Leningrad Regional Clinical Hospital
🇷🇺St. Petersburg, Russian Federation
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Cancer Treatment Services
🇺🇸Corning, New York, United States
Guthrie Clinic
🇺🇸Sayre, New York, United States
Hubert H. Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
San Juan Oncology Association
🇺🇸Farmington, New Mexico, United States
Hematology Oncology Speaclist
🇺🇸Tampa, Florida, United States
Dayton Clinical Oncology Program
🇺🇸Dayton, Ohio, United States
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
Sierra Nevada Oncology Care
🇺🇸Carson City, Nevada, United States
Hospital Dr. Angel Leano
🇲🇽Zapopan, Jalisco, Mexico