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

About this trial
This is an interventional treatment trial for NSCLC focused on measuring Non-small cell lung cancer, NSCLC, PS 2, female, chemotherapy
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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). 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.
Sites / Locations
- Desert Oasis Cancer Center
- Arizona Hematology Oncology
- Genesis Cancer Center
- Heritage Physician Group, Oncology
- Pacific Cancer Medical Center, Inc
- Comprehensive Blood and Cancer Center
- Tower Cancer Research Foundation
- Providence St. Joseph Medical Center
- Hematology/Oncology Group of Fresno, Inc
- Comprehensive Cancer Center-Research Office
- Loma Linda University Cancer Institute
- Pacific Shores Medical Group
- Medical Oncology Care Associates
- The Cancer Research and Prevention Center
- Bethesda Research Center
- Broward Oncology Associates
- Florida Wellcare
- Cancer & Blood Disease Center
- Oncology-Hematology Associates of West Broward
- Hematology Oncology Speaclist
- Joliet Oncology Hematology Associates, Ltd.
- Loyola University Health Systems
- Mid-Illinois HEM & ONC Assoc.
- Northern Indiana Cancer Research Consortium
- Associated Physicians & Surgeons Clinic
- Kentucky Cancer Clinic
- West Kentucky Hematology & Oncology Group, PSC
- Cabrini Center for Cancer Care
- West Michigan Cancer Center
- Oncology Care Associates, PLLC
- Hubert H. Humphrey Cancer Center
- St. Louis Cancer Care Center
- Columbia Comprehensive Cancer Care Clinics
- Bond Clinic
- Saint Louis University
- Washington University Siteman Cancer Center Pharmacy
- Montana Cancer Specialists
- Sierra Nevada Oncology Care
- Essex Oncology of North Jersey, PA
- Atlanta HEM ONC
- Oncology and Hematology Specialist, PA
- San Juan Oncology Association
- Our Lady of Mercy Medical Center
- Suny Downstate Medical Center
- Cancer Treatment Services
- Interlakes Foundation, Inc.
- Guthrie Clinic
- New York Medical Collegw
- Alamance Cancer Center
- UNC Chapel Hill Oncology Protocol Office
- Leo Jenkins Cancer Center
- Northwestern Carolina Oncology & Hematology
- St. Alexius Medical Center
- University of Cleveland
- Metro Health Medical Center
- The Cleveland Clinic Foundation, Taussig Cancer Center
- Dayton Clinical Oncology Program
- Signal Point Hematology/Oncology, Inc.
- Charleston Hematology Oncology
- The Family Cancer Center
- Mary Crowley Medical Research Center
- JPS Center for Cancer Care
- Columbia Basin HEM/ONC
- Sanatorio Parque
- CETEN
- Hospital Privado de Comunidad
- Hospital General de Agudos "Dr Teodoro Alvarez"
- Instituto Alexander Fleming
- Instituto Oncologico de Cordoba - IONC
- LUCEN
- ISIS Clinica Especializada
- District Oncology Dispensary
- District Oncolodispensary with Impatient sector
- Military Medical Academy
- Regional Oncology Dispensary with Inpatient Secot-Sofia District
- Regional Oncology Dispensary with Inpatient Sector
- University Mulitprofile Hospital for Active Treatment "Sveta Marina"
- University Multiprofile Hospital for Active Treatment "Sveta Marina"
- Regional Oncology Dispensary with Inpatient sector
- Jewish General Hospital
- Erzsebet Juhasz
- University of Debrecen, Pulmonology Clinic
- Hospital for Thoracic Diseases of Csongrad Country
- Pulmonology Institute of Veszprem County
- Hospital for Pulmonological Diseases of the Bekes County
- Hospital of the Chest Desease of the Hungarian Reformed Church
- Karolina Hospital
- Barany County Hospital
- Erzsebet Hospital
- Sanatorium for Pulmonological Diseases
- Centenario Hospital Miguel Hidalgo
- CIMA Chihuahua
- Hospital General
- Instituto Estatal de Cancerologia "Dr. Arturo Beltran Ortega"
- Hospital Dr. Angel Leano
- Hospital Star Medica Morelina
- Monterrey International Research Center
- Centro Estatal de Canceologia
- Centro Anticanceroso de la Cruz Roja Mexicana de Merida
- Centro Estatal de Cancerologia
- Hospital Central "Dr. Ignacio Morones Prieto"
- Hospital General Regional
- Kujawsko-Pomorskie Centrum Pulmunologii
- Krakowski Szpital Specjelistyczny
- Centrum Onkologii Ziemii Lubelskiej
- Zaklad Opieki Zdrowotnej Ministerstaw Spraw Wewnetrznych i Administraeji
- Mazowleckie Centrum leczenia Chorob Pluc i Gruzlicy
- Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Samodzielmy Publiczny ZOZ
- SPSK nr l im. Przemienienia AM w Poznaniu
- MSc Grezegorz Jedrejezak
- Dolnoslaskie Centrum Chorob Pluc ul. Grabiszynska 105
- Institutul Oncologie - Clinic de Oncologie Medicala
- Prof. Dr. Al. Trestioreanu Institute of Oncology
- "Prof. Dr. I. Chiricuta" Institute of Oncology
- Emergency Clinical County Hospital
- Oradea Clinical County Hospital
- Clinical County Hospital
- Timisoara Emergency Clinical Municipal Hospital
- Chelyabinsk Regional Oncology Center
- Krasnodar City Oncology Center
- Moscow Municpal Oncology Hospital #62
- Moscow Oncology Clinical Dispensary #1
- SI Russian Oncological Scientific Center after N.N. Blokhim RAMS
- SI Russian Oncological Scientific Center after N.N. Blokhin RAMS
- Centeral ClinicalHospital of the President o the Russian Federation
- Omsk Regional Oncology Center
- Orenburg Regional Oncology Clinical Center
- St. Petersburg City Clinical Oncology Center
- Lenigrad Regional Oncology Center
- Leningrad Regional Clinical Hospital
- St. Petersbrug State Medical Pavlov University
- Donetsk Regional Antineoplastic Center
- Ivano-Frankovsk Regional Oncology Center, Ivano-Frankovsk Medical University
- Instiute of Oncology under AMS of Ukraine
- Volyn Regional Oncology Dispensary
- Uzhgorod National University, Regional Clinical Oncology Dispensary
- Vinnitsa State Medical University
- Zaporizhzhya Regional Oncology Dispensary
- The Royal Bournemouth Hospital
- Oncology Pharmacy
- Wythenshaw Hospital, Pharmacy Department
- Southhampton General Hospital