Clinical trial NCT00269828: A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: NSCLC
Keywords: Non-small cell lung cancer
NSCLC
PS 2
female
chemotherapy
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

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