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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00269828
Other study ID # PGT305
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 2005
Est. completion date December 2006

Study information

Verified date November 2020
Source CTI BioPharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

See Summary


Other known NCT identifiers
  • NCT00317824

Recruitment information / eligibility

Status Terminated
Enrollment 600
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Female. 2. Histologically- or cytologically-confirmed diagnosis of NSCLC. 3. ECOG performance score of 2. 4. 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. 5. Age greater than or equal to 18 years. 6. Adequate bone marrow function 7. Adequate renal function 8. Adequate hepatic function 9. Patients with known brain metastases must have received standard antitumor treatment for their CNS metastases as defined by the site's institutional standards. 10. Patients who have had major surgery must be fully recovered from the surgery. 11. Ability to comply with the visit schedule and assessments required by the protocol. 12. For patients of reproductive potential, commitment to use adequate contraception. 13. Signed approved informed consent, with understanding of study procedures. 14. Agreement to begin study therapy within 8 calendar days after randomization. Exclusion Criteria: 1. Any intolerance to poly-L-glutamic acid, Poloxamer 188, dibasic sodium phosphate, monobasic sodium phosphate (the excipients of CT-2103). 2. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell histology. 3. Any prior systemic chemotherapy for the treatment of lung cancer. This includes systemic radiosensitizers used to treat brain metastases and any biologic agent. 4. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer. 5. Grade 2 or greater neuropathy. 6. 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). 7. Clinically significant active infection for which active therapy is underway. 8. Investigational therapy within 4 weeks before randomization, unless local requirements are more stringent. 9. 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. 10. Pregnant women or nursing mothers. 11. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
paclitaxel

paclitaxel poliglumex


Locations

Country Name City State
Argentina CETEN Beunos Aires
Argentina Hospital General de Agudos "Dr Teodoro Alvarez" Buenos Aires
Argentina Hospital Privado de Comunidad Buenos Aires
Argentina Instituto Alexander Fleming Ciudad de Buenos Aires
Argentina Instituto Oncologico de Cordoba - IONC Cordoba
Argentina LUCEN Cuidad Autonoma de Buenos Aires
Argentina Sanatorio Parque Rosario Santa Fe
Argentina ISIS Clinica Especializada Urquiza
Bulgaria District Oncology Dispensary Plovdiv
Bulgaria District Oncolodispensary with Impatient sector Rousse
Bulgaria Military Medical Academy Sofia
Bulgaria Regional Oncology Dispensary with Inpatient Secot-Sofia District Sogia
Bulgaria Regional Oncology Dispensary with Inpatient Sector Varna
Bulgaria University Mulitprofile Hospital for Active Treatment "Sveta Marina" Varna
Bulgaria University Multiprofile Hospital for Active Treatment "Sveta Marina" Varna
Bulgaria Regional Oncology Dispensary with Inpatient sector Veliko Tarnovo
Canada Jewish General Hospital Montreal Quebec
Hungary Erzsebet Juhasz Budapest
Hungary University of Debrecen, Pulmonology Clinic Debreen
Hungary Hospital for Thoracic Diseases of Csongrad Country Deszk
Hungary Pulmonology Institute of Veszprem County Farkasgyepu
Hungary Hospital for Pulmonological Diseases of the Bekes County Gyula
Hungary Hospital of the Chest Desease of the Hungarian Reformed Church Mosdos
Hungary Karolina Hospital Mosonmagyarovar
Hungary Barany County Hospital Pecs
Hungary Erzsebet Hospital Sopron
Hungary Sanatorium for Pulmonological Diseases Torokbalint
Mexico Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega" Acapulco Gro
Mexico Centenario Hospital Miguel Hidalgo Aguascalientes Ags.
Mexico Centro Estatal de Cancerologia Chihuahua
Mexico CIMA Chihuahua Chihuahua Chih
Mexico Hospital General Durango Dgo.
Mexico Centro Estatal de Canceologia Jalapa Veracruz
Mexico Centro Anticanceroso de la Cruz Roja Mexicana de Merida Merida Yucatan
Mexico Monterrey International Research Center Monterrey N.l.
Mexico Hospital Star Medica Morelina Morelia Michoacan
Mexico Hospital Central "Dr. Ignacio Morones Prieto" San Luis Potosi
Mexico Hospital General Regional Veracruz
Mexico Hospital Dr. Angel Leano Zapopan Jalisco
Poland Kujawsko-Pomorskie Centrum Pulmunologii Bydgoszcz
Poland Krakowski Szpital Specjelistyczny Kawkow
Poland Centrum Onkologii Ziemii Lubelskiej Lublin
Poland Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji Olsztyn
Poland Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy Otwock
Poland SPSK nr l im. Przemienienia AM w Poznaniu Poznan
Poland Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ Poznan
Poland Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105 Wroclaw
Poland MSc Grezegorz Jedrejezak Wroclaw
Romania Institutul Oncologie - Clinic de Oncologie Medicala Bucharest
Romania Prof. Dr. Al. Trestioreanu Institute of Oncology Bucharest
Romania "Prof. Dr. I. Chiricuta" Institute of Oncology Cluj-Napoca
Romania Emergency Clinical County Hospital Craiova
Romania Oradea Clinical County Hospital Oradea
Romania Clinical County Hospital Sibiu
Romania Timisoara Emergency Clinical Municipal Hospital Timisoara
Russian Federation Chelyabinsk Regional Oncology Center Chelyabinsk
Russian Federation Krasnodar City Oncology Center Krasnodar
Russian Federation Centeral ClinicalHospital of the President o the Russian Federation Moscow
Russian Federation Moscow Oncology Clinical Dispensary #1 Moscow
Russian Federation SI Russian Oncological Scientific Center after N.N. Blokhim RAMS Moscow
Russian Federation SI Russian Oncological Scientific Center after N.N. Blokhin RAMS Moscow
Russian Federation Moscow Municpal Oncology Hospital #62 Moscow Region
Russian Federation Omsk Regional Oncology Center Omsk
Russian Federation Orenburg Regional Oncology Clinical Center Orenburg
Russian Federation St. Petersburg City Clinical Oncology Center Saint Petersburg
Russian Federation Lenigrad Regional Oncology Center St. Petersburg
Russian Federation Leningrad Regional Clinical Hospital St. Petersburg
Russian Federation St. Petersbrug State Medical Pavlov University St. Petersburg
Ukraine Donetsk Regional Antineoplastic Center Donetsk
Ukraine Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University Ivano-Frankovsk
Ukraine Instiute of Oncology under AMS of Ukraine Kiev
Ukraine Volyn Regional Oncology Dispensary Lutsk
Ukraine Uzhgorod National University, Regional Clinical Oncology Dispensary Uzhgorod
Ukraine Vinnitsa State Medical University Vynnytsya
Ukraine Zaporizhzhya Regional Oncology Dispensary Zaprizhzhya
United Kingdom The Royal Bournemouth Hospital Bournemouth
United Kingdom Oncology Pharmacy London
United Kingdom Wythenshaw Hospital, Pharmacy Department Manchester
United Kingdom Southhampton General Hospital Southhampton
United States Cabrini Center for Cancer Care Alexandria Louisiana
United States Pacific Cancer Medical Center, Inc Anaheim California
United States Comprehensive Blood and Cancer Center Bakersfield California
United States Essex Oncology of North Jersey, PA Belleville New Jersey
United States Tower Cancer Research Foundation Beverly Hills California
United States St. Alexius Medical Center Bismarck North Dakota
United States Bethesda Research Center Boynton Beach Florida
United States Our Lady of Mercy Medical Center Bronx New York
United States Suny Downstate Medical Center Brooklyn New York
United States Providence St. Joseph Medical Center Burbank California
United States Alamance Cancer Center Burlington North Carolina
United States Sierra Nevada Oncology Care Carson City Nevada
United States Desert Oasis Cancer Center Casa Grande Arizona
United States UNC Chapel Hill Oncology Protocol Office Chapel Hill North Carolina
United States Charleston Hematology Oncology Charleston South Carolina
United States St. Louis Cancer Care Center Chesterfield Missouri
United States Metro Health Medical Center Cleveland Ohio
United States The Cleveland Clinic Foundation, Taussig Cancer Center Cleveland Ohio
United States University of Cleveland Cleveland Ohio
United States The Family Cancer Center Collierville Tennessee
United States Columbia Comprehensive Cancer Care Clinics Columbia Missouri
United States Cancer Treatment Services Corning New York
United States Mary Crowley Medical Research Center Dallas Texas
United States Dayton Clinical Oncology Program Dayton Ohio
United States San Juan Oncology Association Farmington New Mexico
United States Broward Oncology Associates Fort Lauderdale Florida
United States JPS Center for Cancer Care Fort Worth Texas
United States Hematology/Oncology Group of Fresno, Inc Fresno California
United States Comprehensive Cancer Center-Research Office Glendale California
United States Leo Jenkins Cancer Center Greenville North Carolina
United States Kentucky Cancer Clinic Hazard Kentucky
United States Northwestern Carolina Oncology & Hematology Hickory North Carolina
United States Genesis Cancer Center Hot Springs Arkansas
United States Heritage Physician Group, Oncology Hot Springs Arkansas
United States Florida Wellcare Inverness Florida
United States Joliet Oncology Hematology Associates, Ltd. Joliet Illinois
United States West Michigan Cancer Center Kalamazoo Michigan
United States Columbia Basin HEM/ONC Kennewick Washington
United States Cancer & Blood Disease Center Lecanto Florida
United States Loma Linda University Cancer Institute Loma Linda California
United States Pacific Shores Medical Group Long Beach California
United States Atlanta HEM ONC Manasquan New Jersey
United States Loyola University Health Systems Maywood Illinois
United States Signal Point Hematology/Oncology, Inc. Middletown Ohio
United States Montana Cancer Specialists Missoula Montana
United States Oncology and Hematology Specialist, PA Mountain Lakes New Jersey
United States Mid-Illinois HEM & ONC Assoc. Normal Illinois
United States Medical Oncology Care Associates Orange California
United States West Kentucky Hematology & Oncology Group, PSC Paducah Kentucky
United States Hubert H. Humphrey Cancer Center Robbinsdale Minnesota
United States Interlakes Foundation, Inc. Rochester New York
United States Bond Clinic Rolla Missouri
United States Oncology Care Associates, PLLC Saint Joseph Michigan
United States Saint Louis University Saint Louis Missouri
United States Washington University Siteman Cancer Center Pharmacy Saint Louis Missouri
United States Guthrie Clinic Sayre New York
United States The Cancer Research and Prevention Center Soquel California
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Oncology-Hematology Associates of West Broward Tamarac Florida
United States Hematology Oncology Speaclist Tampa Florida
United States Associated Physicians & Surgeons Clinic Terre Haute Indiana
United States Arizona Hematology Oncology Tucson Arizona
United States New York Medical Collegw Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
CTI BioPharma

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Hungary,  Mexico,  Poland,  Romania,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
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