Full Text View
Tabular View
No Study Results Posted
Related Studies
A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
This study has been terminated.
First Received: December 22, 2005   Last Updated: February 13, 2007   History of Changes
Sponsored by: Cell Therapeutics
Information provided by: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00269828
  Purpose

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


Condition Intervention Phase
NSCLC
Drug: paclitaxel
Drug: paclitaxel poliglumex
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Paclitaxel Poliglumex
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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.

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 600
Study Start Date: December 2005
Estimated Study Completion Date: December 2006
Detailed Description:

See Summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269828

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

No publications provided

Study ID Numbers: PGT305, PIONEER
Study First Received: December 22, 2005
Last Updated: February 13, 2007
ClinicalTrials.gov Identifier: NCT00269828     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
Non-small cell lung cancer
NSCLC
PS 2
female
chemotherapy

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 12, 2009