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NSCLCPhase 3PIONEERNCT00269828

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

A Phase 3 study testing paclitaxel and paclitaxel poliglumex in people with NSCLC, run by CTI BioPharma at 143 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
NSCLC
What is being tested?
paclitaxel and paclitaxel poliglumex
How many people
600 participants
Where
143 sitesin 11 countries
Study dates
Dec 2005to Dec 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
Show all 11Show fewer
  • 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.

Trial locations and contacts

143 sites in 11 countries.

143 sites in 11 countries

United States64 sites

  • Cabrini Center for Cancer Care

    Alexandria, Louisiana, 71301

  • Pacific Cancer Medical Center, Inc

    Anaheim, California, 92801

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Essex Oncology of North Jersey, PA

    Belleville, New Jersey, 07109

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • St. Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Bethesda Research Center

    Boynton Beach, Florida, 33435

  • Suny Downstate Medical Center

    Brooklyn, New York, 11203

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • Alamance Cancer Center

    Burlington, North Carolina, 27215

  • Sierra Nevada Oncology Care

    Carson City, Nevada, 89100

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85222

  • UNC Chapel Hill Oncology Protocol Office

    Chapel Hill, North Carolina, 27599

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29403

  • St. Louis Cancer Care Center

    Chesterfield, Missouri, 63017

  • University of Cleveland

    Cleveland, Ohio, 44106

  • Metro Health Medical Center

    Cleveland, Ohio, 44109

  • The Cleveland Clinic Foundation, Taussig Cancer Center

    Cleveland, Ohio, 44195

  • The Family Cancer Center

    Collierville, Tennessee, 38077

  • Columbia Comprehensive Cancer Care Clinics

    Columbia, Missouri, 65201

  • Cancer Treatment Services

    Corning, New York, 14830

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75201

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45429

  • San Juan Oncology Association

    Farmington, New Mexico, 87401

  • Broward Oncology Associates

    Fort Lauderdale, Florida, 33308

  • JPS Center for Cancer Care

    Fort Worth, Texas, 76104

  • Hematology/Oncology Group of Fresno, Inc

    Fresno, California, 93720

  • Comprehensive Cancer Center-Research Office

    Glendale, California, 91204

  • Leo Jenkins Cancer Center

    Greenville, North Carolina, 28734

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701

  • Northwestern Carolina Oncology & Hematology

    Hickory, North Carolina, 28602

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Heritage Physician Group, Oncology

    Hot Springs, Arkansas, 71913

  • Florida Wellcare

    Inverness, Florida, 34452

  • Joliet Oncology Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Columbia Basin HEM/ONC

    Kennewick, Washington, 99336

  • Cancer & Blood Disease Center

    Lecanto, Florida, 34461

  • Loma Linda University Cancer Institute

    Loma Linda, California, 92354

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Atlanta HEM ONC

    Manasquan, New Jersey, 08736

  • Loyola University Health Systems

    Maywood, Illinois, 60153

  • Signal Point Hematology/Oncology, Inc.

    Middletown, Ohio, 45042

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Oncology and Hematology Specialist, PA

    Mountain Lakes, New Jersey, 07046

  • Mid-Illinois HEM & ONC Assoc.

    Normal, Illinois, 61761

  • Medical Oncology Care Associates

    Orange, California, 92868

  • West Kentucky Hematology & Oncology Group, PSC

    Paducah, Kentucky, 42003

  • Hubert H. Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • Interlakes Foundation, Inc.

    Rochester, New York, 14623

  • Bond Clinic

    Rolla, Missouri, 65401

  • Oncology Care Associates, PLLC

    Saint Joseph, Michigan, 49085

  • Guthrie Clinic

    Sayre, New York, 18840

  • The Cancer Research and Prevention Center

    Soquel, California, 95073

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University Siteman Cancer Center Pharmacy

    St Louis, Missouri, 63110

  • Oncology-Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Hematology Oncology Speaclist

    Tampa, Florida, 33607

  • Associated Physicians & Surgeons Clinic

    Terre Haute, Indiana, 47804

  • Our Lady of Mercy Medical Center

    The Bronx, New York, 10466

  • Study site

    Troy, Michigan, 48085

  • Arizona Hematology Oncology

    Tucson, Arizona, 85704

  • New York Medical Collegw

    Valhalla, New York, 10595

Other trials in United States

Russia13 sites

  • Chelyabinsk Regional Oncology Center

    Chelyabinsk, 454087

  • Krasnodar City Oncology Center

    Krasnodar, 350040

  • Moscow Oncology Clinical Dispensary #1

    Moscow, 109033

  • SI Russian Oncological Scientific Center after N.N. Blokhim RAMS

    Moscow, 115478

  • SI Russian Oncological Scientific Center after N.N. Blokhin RAMS

    Moscow, 115478

  • Centeral ClinicalHospital of the President o the Russian Federation

    Moscow, 121356

  • Moscow Municpal Oncology Hospital #62

    Moscow Region, 143423

  • Omsk Regional Oncology Center

    Omsk, 644013

  • Orenburg Regional Oncology Clinical Center

    Orenburg, 460021

  • Lenigrad Regional Oncology Center

    Saint Petersburg, 191104

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • St. Petersbrug State Medical Pavlov University

    Saint Petersburg, 197089

  • St. Petersburg City Clinical Oncology Center

    Saint Petersburg, 198255

Other trials in Russia

Mexico12 sites

  • Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega"

    Acapulco de Juárez, Guerrero, 39570

  • Centenario Hospital Miguel Hidalgo

    Aguascalientes, Aguascalientes, 20230

  • CIMA Chihuahua

    Chihuahua City, Chih, 31238

  • Centro Estatal de Cancerologia

    Chihuahua City, 31000

  • Hospital General

    Durango, Durango, 34079

  • Centro Estatal de Canceologia

    Jalapa, Veracruz, 31238

  • Centro Anticanceroso de la Cruz Roja Mexicana de Merida

    Mérida, Yucatán, 9700

  • Monterrey International Research Center

    Monterrey, N.L., 64020

  • Hospital Star Medica Morelina

    Morelia, Michoacán, 58070

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, 78240

  • Hospital General Regional

    Veracruz, 91700

  • Hospital Dr. Angel Leano

    Zapopan, Jalisco, 45200

Other trials in Mexico

Hungary10 sites

  • Erzsebet Juhasz

    Budapest, 1529

  • University of Debrecen, Pulmonology Clinic

    Debreen, 4032

  • Hospital for Thoracic Diseases of Csongrad Country

    Deszk, 6772

  • Pulmonology Institute of Veszprem County

    Farkasgyepű, 8582

  • Hospital for Pulmonological Diseases of the Bekes County

    Gyula, 5703

  • Hospital of the Chest Desease of the Hungarian Reformed Church

    Mosdós, 7257

  • Karolina Hospital

    Mosonmagyaróvár, 9200

  • Barany County Hospital

    Pécs, 7623

  • Erzsebet Hospital

    Sopron, 9400

  • Sanatorium for Pulmonological Diseases

    Törökbálint, 2045

Other trials in Hungary

Poland9 sites

  • Kujawsko-Pomorskie Centrum Pulmunologii

    Bydgoszcz, 85-326

  • Krakowski Szpital Specjelistyczny

    Kawkow, 31-202

  • Centrum Onkologii Ziemii Lubelskiej

    Lublin, 20-090

  • Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji

    Olsztyn, 10-228

  • Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ

    Poznan, 60-569

  • SPSK nr l im. Przemienienia AM w Poznaniu

    Poznan, 61-848

  • MSc Grezegorz Jedrejezak

    Wroclaw, 50-891

  • Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105

    Wroclaw, 53-439

Other trials in Poland

Argentina8 sites

  • CETEN

    Beunos Aires, B1874ACL

  • Hospital Privado de Comunidad

    Buenos Aires, B7602CBM

  • Hospital General de Agudos "Dr Teodoro Alvarez"

    Buenos Aires, C1406FWY

  • Instituto Alexander Fleming

    Ciudad de Buenos Aires, C1426ANZ

  • Instituto Oncologico de Cordoba - IONC

    Córdoba, X5000AA1

  • LUCEN

    Cuidad Autonoma de Buenos Aires, C1405CUB

  • Sanatorio Parque

    Rosario, Santa Fe Province, S2000DSV

  • ISIS Clinica Especializada

    Urquiza, 3022

Other trials in Argentina

Bulgaria8 sites

  • District Oncology Dispensary

    Plovdiv, 4000

  • District Oncolodispensary with Impatient sector

    Rousse, 7002

  • Military Medical Academy

    Sofia, 1606

  • Regional Oncology Dispensary with Inpatient Secot-Sofia District

    Sogia, 1233

  • Regional Oncology Dispensary with Inpatient Sector

    Varna, 9010

  • University Mulitprofile Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

  • Regional Oncology Dispensary with Inpatient sector

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Romania7 sites

  • Institutul Oncologie - Clinic de Oncologie Medicala

    Bucharest, 022328

  • Prof. Dr. Al. Trestioreanu Institute of Oncology

    Bucharest, 022328

  • "Prof. Dr. I. Chiricuta" Institute of Oncology

    Cluj-Napoca, 400015

  • Emergency Clinical County Hospital

    Craiova, 200642

  • Oradea Clinical County Hospital

    Oradea, 410032

  • Clinical County Hospital

    Sibiu, 550245

  • Timisoara Emergency Clinical Municipal Hospital

    Timișoara, 300223

Other trials in Romania

Ukraine7 sites

  • Donetsk Regional Antineoplastic Center

    Donetsk, 83092

  • Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University

    Ivano-Frankivsk, 76018

  • Instiute of Oncology under AMS of Ukraine

    Kiev, 3022

  • Volyn Regional Oncology Dispensary

    Lutsk, 43018

  • Uzhgorod National University, Regional Clinical Oncology Dispensary

    Uzhhorod, 88014

  • Vinnitsa State Medical University

    Vynnytsya, 21029

  • Zaporizhzhya Regional Oncology Dispensary

    Zaprizhzhya, 69040

Other trials in Ukraine

United Kingdom4 sites

  • The Royal Bournemouth Hospital

    Bournemouth, BH77DW

  • Oncology Pharmacy

    London, SE19RT

  • Wythenshaw Hospital, Pharmacy Department

    Manchester, M23 9LT

  • Southhampton General Hospital

    Southhampton, SO16 6YD

Other trials in United Kingdom

Canada1 site

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

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.

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

Read the detailed description

See Summary

Conditions
NSCLC
Being tested
paclitaxel, paclitaxel poliglumex
Keywords
Non-small cell lung cancer, NSCLC, PS 2, female, chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269828
Sponsor's protocol ID
PGT305
Acronym
PIONEER
Status last verified
Nov 2020
First submitted
22 Dec 2005
Last updated
24 Nov 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paclitaxel and paclitaxel poliglumex in people with NSCLC, run by CTI BioPharma at 143 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Russia, Mexico, Hungary, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00269828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.

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