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

November 23, 2020 updated by: CTI BioPharma

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.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

See Summary

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Beunos Aires, Argentina, B1874ACL
        • Ceten
      • Buenos Aires, Argentina, B7602CBM
        • Hospital Privado de Comunidad
      • Buenos Aires, Argentina, C1406FWY
        • Hospital General de Agudos "Dr Teodoro Alvarez"
      • Ciudad de Buenos Aires, Argentina, C1426ANZ
        • Instituto Alexander Fleming
      • Cordoba, Argentina, X5000AA1
        • Instituto Oncologico de Cordoba - IONC
      • Cuidad Autonoma de Buenos Aires, Argentina, C1405CUB
        • LUCEN
      • Urquiza, Argentina, 3022
        • ISIS Clinica Especializada
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Sanatorio Parque
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • District Oncology Dispensary
      • Rousse, Bulgaria, 7002
        • District Oncolodispensary with Impatient sector
      • Sofia, Bulgaria, 1606
        • Military Medical Academy
      • Sogia, Bulgaria, 1233
        • Regional Oncology Dispensary with Inpatient Secot-Sofia District
      • Varna, Bulgaria, 9010
        • University Multiprofile Hospital for Active Treatment "Sveta Marina"
      • Varna, Bulgaria, 9010
        • Regional Oncology Dispensary with Inpatient sector
      • Varna, Bulgaria, 9010
        • University Mulitprofile Hospital for Active Treatment "Sveta Marina"
      • Veliko Tarnovo, Bulgaria, 5000
        • Regional Oncology Dispensary with Inpatient sector
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Hungary
      • Budapest, Hungary, 1529
        • Erzsebet Juhasz
      • Debreen, Hungary, 4032
        • University of Debrecen, Pulmonology Clinic
      • Deszk, Hungary, 6772
        • Hospital for Thoracic Diseases of Csongrad Country
      • Farkasgyepu, Hungary, 8582
        • Pulmonology Institute of Veszprem County
      • Gyula, Hungary, 5703
        • Hospital for Pulmonological Diseases of the Bekes County
      • Mosdos, Hungary, 7257
        • Hospital of the Chest Desease of the Hungarian Reformed Church
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Hospital
      • Pecs, Hungary, 7623
        • Barany County Hospital
      • Sopron, Hungary, 9400
        • Erzsebet Hospital
      • Torokbalint, Hungary, 2045
        • Sanatorium for Pulmonological Diseases
  • Mexico
      • Chihuahua, Mexico, 31000
        • Centro Estatal de Cancerologia
      • San Luis Potosi, Mexico, 78240
        • Hospital Central "Dr. Ignacio Morones Prieto"
      • Veracruz, Mexico, 91700
        • Hospital General Regional
    • Ags.
      • Aguascalientes, Ags., Mexico, 20230
        • Centenario Hospital Miguel Hidalgo
    • Chih
      • Chihuahua, Chih, Mexico, 31238
        • CIMA Chihuahua
    • Dgo.
      • Durango, Dgo., Mexico, 34079
        • Hospital General
    • Gro
      • Acapulco, Gro, Mexico, 39570
        • Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega"
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45200
        • Hospital Dr. Ángel Leaño
    • Michoacan
      • Morelia, Michoacan, Mexico, 58070
        • Hospital Star Medica Morelina
    • N.l.
      • Monterrey, N.l., Mexico, 64020
        • Monterrey International Research Center
    • Veracruz
      • Jalapa, Veracruz, Mexico, 31238
        • Centro Estatal de Canceologia
    • Yucatan
      • Merida, Yucatan, Mexico, 9700
        • Centro Anticanceroso de la Cruz Roja Mexicana de Mérida
  • Poland
      • Bydgoszcz, Poland, 85-326
        • Kujawsko-Pomorskie Centrum Pulmunologii
      • Kawkow, Poland, 31-202
        • Krakowski Szpital Specjelistyczny
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemii Lubelskiej
      • Olsztyn, Poland, 10-228
        • Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji
      • Otwock, Poland, 05-400
        • Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy
      • Poznan, Poland, 60-569
        • Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ
      • Poznan, Poland, 61-848
        • SPSK nr l im. Przemienienia AM w Poznaniu
      • Wroclaw, Poland, 50-891
        • MSc Grezegorz Jedrejezak
      • Wroclaw, Poland, 53-439
        • Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Oncologie - Clinic de Oncologie Medicala
      • Bucharest, Romania, 022328
        • Prof. Dr. Al. Trestioreanu Institute of Oncology
      • Cluj-Napoca, Romania, 400015
        • "Prof. Dr. I. Chiricuta" Institute of Oncology
      • Craiova, Romania, 200642
        • Emergency Clinical County Hospital
      • Oradea, Romania, 410032
        • Oradea Clinical County Hospital
      • Sibiu, Romania, 550245
        • Clinical county Hospital
      • Timisoara, Romania, 300223
        • Timisoara Emergency Clinical Municipal Hospital
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Center
      • Krasnodar, Russian Federation, 350040
        • Krasnodar City Oncology Center
      • Moscow, Russian Federation, 109033
        • Moscow Oncology Clinical Dispensary #1
      • Moscow, Russian Federation, 115478
        • SI Russian Oncological Scientific Center after N.N. Blokhim RAMS
      • Moscow, Russian Federation, 115478
        • SI Russian Oncological Scientific Center after N.N. Blokhin RAMS
      • Moscow, Russian Federation, 121356
        • Centeral ClinicalHospital of the President o the Russian Federation
      • Moscow Region, Russian Federation, 143423
        • Moscow Municpal Oncology Hospital #62
      • Omsk, Russian Federation, 644013
        • Omsk Regional Oncology Center
      • Orenburg, Russian Federation, 460021
        • Orenburg Regional Oncology Clinical Center
      • Saint Petersburg, Russian Federation, 198255
        • St. Petersburg City Clinical Oncology Center
      • St. Petersburg, Russian Federation, 194291
        • Leningrad Regional Clinical Hospital
      • St. Petersburg, Russian Federation, 191104
        • Lenigrad Regional Oncology Center
      • St. Petersburg, Russian Federation, 197089
        • St. Petersbrug State Medical Pavlov University
  • Ukraine
      • Donetsk, Ukraine, 83092
        • Donetsk Regional Antineoplastic Center
      • Ivano-Frankovsk, Ukraine, 76018
        • Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University
      • Kiev, Ukraine, 3022
        • Instiute of Oncology under AMS of Ukraine
      • Lutsk, Ukraine, 43018
        • Volyn Regional Oncology Dispensary
      • Uzhgorod, Ukraine, 88014
        • Uzhgorod National University, Regional Clinical Oncology Dispensary
      • Vynnytsya, Ukraine, 21029
        • Vinnitsa State Medical University
      • Zaprizhzhya, Ukraine, 69040
        • Zaporizhzhya Regional Oncology Dispensary
  • United Kingdom
      • Bournemouth, United Kingdom, BH77DW
        • The Royal Bournemouth Hospital
      • London, United Kingdom, SE19RT
        • Oncology Pharmacy
      • Manchester, United Kingdom, M23 9LT
        • Wythenshaw Hospital, Pharmacy Department
      • Southhampton, United Kingdom, SO16 6YD
        • Southhampton General Hospital
  • United States
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Desert Oasis Cancer Center
      • Tucson, Arizona, United States, 85704
        • Arizona Hematology Oncology
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physician Group, Oncology
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center
      • Fresno, California, United States, 93720
        • Hematology/Oncology Group of Fresno, Inc
      • Glendale, California, United States, 91204
        • Comprehensive Cancer Center-Research Office
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • Soquel, California, United States, 95073
        • The Cancer Research and Prevention Center
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Bethesda Research Center
      • Fort Lauderdale, Florida, United States, 33308
        • Broward Oncology Associates
      • Inverness, Florida, United States, 34452
        • Florida Wellcare
      • Lecanto, Florida, United States, 34461
        • Cancer & Blood Disease Center
      • Tamarac, Florida, United States, 33321
        • Oncology-Hematology Associates of West Broward
      • Tampa, Florida, United States, 33607
        • Hematology Oncology Speaclist
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology Hematology Associates, Ltd.
      • Maywood, Illinois, United States, 60153
        • Loyola University Health Systems
      • Normal, Illinois, United States, 61761
        • Mid-Illinois HEM & ONC Assoc.
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute, Indiana, United States, 47804
        • Associated Physicians & Surgeons Clinic
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
      • Paducah, Kentucky, United States, 42003
        • West Kentucky Hematology & Oncology Group, PSC
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cabrini Center for Cancer Care
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Saint Joseph, Michigan, United States, 49085
        • Oncology Care Associates, PLLC
      • Troy, Michigan, United States, 48085
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Louis Cancer Care Center
      • Columbia, Missouri, United States, 65201
        • Columbia Comprehensive Cancer Care Clinics
      • Rolla, Missouri, United States, 65401
        • Bond Clinic
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63110
        • Washington University Siteman Cancer Center Pharmacy
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nevada
      • Carson City, Nevada, United States, 89100
        • Sierra Nevada Oncology Care
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Essex Oncology of North Jersey, PA
      • Manasquan, New Jersey, United States, 08736
        • Atlanta HEM ONC
      • Mountain Lakes, New Jersey, United States, 07046
        • Oncology and Hematology Specialist, PA
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Association
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Corning, New York, United States, 14830
        • Cancer Treatment Services
      • Rochester, New York, United States, 14623
        • Interlakes Foundation, Inc.
      • Sayre, New York, United States, 18840
        • Guthrie Clinic
      • Valhalla, New York, United States, 10595
        • New York Medical Collegw
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Alamance Cancer Center
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill Oncology Protocol Office
      • Greenville, North Carolina, United States, 28734
        • Leo Jenkins Cancer Center
      • Hickory, North Carolina, United States, 28602
        • Northwestern Carolina Oncology & Hematology
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • St. Alexius Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Metro Health Medical Center
      • Cleveland, Ohio, United States, 44106
        • University of Cleveland
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation, Taussig Cancer Center
      • Dayton, Ohio, United States, 45429
        • Dayton Clinical Oncology Program
      • Middletown, Ohio, United States, 45042
        • Signal Point Hematology/Oncology, Inc.
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
    • Tennessee
      • Collierville, Tennessee, United States, 38077
        • The Family Cancer Center
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Medical Research Center
      • Fort Worth, Texas, United States, 76104
        • JPS Center for Cancer Care
    • Washington
      • Kennewick, Washington, United States, 99336
        • Columbia Basin HEM/ONC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CTI BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGT305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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