A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.

NSCLC Clinical Trial

— PIONEER  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00269828
• Other study ID #: PGT305
• Status: Terminated
• Phase: Phase 3
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• NSCLC

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.