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Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

Inclusion Criteria


INCLUSION CRITERIA:

- Men or women age 18 years or older

- Histologically or cytologically confirmed NSCLC

- Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)

- Patients with Stage IIIB NSCLC must have a cytologically documented pleural
effusion

- Failed or relapsed after receiving a platinum-containing chemotherapy regimen as
first-line therapy for advanced NSCLC

- Measurable disease on computerized tomography (CT) scan

- ECOG Performance Status of 0 or 1

- Expected survival ≥12 weeks

- Provide written informed consent

EXCLUSION CRITERIA:

- More than 2 prior chemotherapy regimens

- Clinically significant laboratory abnormalities, specifically:

- Total bilirubin ≥ institutional upper limit of normal (ULN)

- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x
ULN concomitant with alkaline phosphatase >2.5 x ULN

- Serum creatinine ≥2.0mg/dL

- Absolute neutrophil count <1500/μL or platelets <100,000/μL

- Untreated or symptomatic brain metastases

- Any malignancy within the 5 years immediately prior to the first dose of study
medication with the exception of basal cell or non-metastatic squamous cell carcinoma
of the skin, and carcinoma in-situ of the cervix

- A history of severe hypersensitivity to drugs formulated with polysorbate 80

- Any comorbidity or condition which, in the opinion of the investigator, may interfere
with the assessments and procedures of this protocol

- Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or
other investigational medication for NSCLC.

- Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must
agree to use a barrier method of contraception.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

PTH-304

NCT ID:

NCT00243204

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Stage IIIb/IV non-small cell lung cancer
  • NSCLC
  • Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

William Beaumont HospitalRoyal Oak, Michigan  48073
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Oncology/Hematology Care, Inc.Cincinnati, Ohio  45219
Rocky Mountain Cancer CentersThornton, Colorado  80260
Mary Crowley Medical Research CenterDallas, Texas  75246
Medical Oncology, LLCBaton Rouge, Louisiana  70808
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
Cancer Care AssociatesTulsa, Oklahoma  74136
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Henry Ford Health SystemDetroit, Michigan  48202
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
University of ChicagoChicago, Illinois  60637
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Gabrail Cancer CenterCanton, Ohio  44718
Texas Oncology, PADallas, Texas  75246-2006
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
Peninsula Cancer InstituteNewport News, Virginia  23601
Kentucky Cancer ClinicPikeville, Kentucky  41501
Mile High OncologyDenver, Colorado  80210
Hematology Oncology AssociatesPhoenix, Arizona  85012
Arch Medical Services, INC.St. Louis, Missouri  63142
Cancer Center of FloridaOcoee, Florida  34761
Indiana Hematology Oncology ConsultantsIndianapolis, Indiana  46202
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
El Paso Cancer Treatment CenterEl Paso, Texas  79915
Texas Cancer Center of MesquiteMesquite, Texas  75150
Cancer Care Institute of CarolinaAiken, South Carolina  29801
Billings ClinicBillings, Montana  59107-7000
Cancer Care Northwest ResearchSpokane, Washington  99218
New York Oncology Hematology, PCAlbany, New York  12208
Puget Sound Cancer CentersEdmonds, Washington  98026
Northwest Cancer Specialists, PCVancouver, Washington  98684
Northern Indiana Oncology AssociatesSouth Bend, Indiana  46617
Mitchell Folbe, MD, PCTroy, Michigan  48085
Paris Regional Cancer CenterParis, Texas  75460
Oncology & Hematology Associates of Southwest Virginia, Inc.Salem, Virginia  24153
Citrus Hematology and Oncology CenterInverness, Florida  34452
Charleston Hematology Oncology, PACharleston, South Carolina  29403
Henry Ford Medical CenterDearborn, Michigan  48126
Cancer and Blood Disease CenterLecanto, Florida  34461
Trilogy Cancer CenterWooster, Ohio  44691
Joliet Oncology Hematology AssociatesJoliet, Illinois  60435
Pasco Hernando Oncology Associates, PANew Port Richey, Florida  34642
Medical Specialists of FairfieldFairfield, Connecticut  
Marshall Schreeder, MDHuntsville, Alabama  35801
James P. Daugherty, MDMuscle Shoals, Alabama  35661
Alaska Cancer ResearchAnchorage, Alaska  99508
Veena Charu, MDAnaheim, California  92801
Lalita Pandit, MD, IncFountain Valley, California  92708
Robert A. Moss, MD, FACP, Inc.Fountain Valley, California  92708
Warren Paroly, MDOceanside, California  92056
Swarna S. Chanduri, MDPomona, California  91767
Southwest Cancer Care Medical GroupPoway, California  92064-2527
Pasco Hernando Oncology Associates PABrooksville, Florida  34613
Lucio Gordan, MDGainesville, Florida  32605
Nature Coast Clinical Research, LLCInverness, Florida  34452
Jorge G. Otoya, MDKissimmee, Florida  34741
Kansas City Cancer Centers, SouthwestOverland Park, Kansas  66210
Maryland Oncology Hematology, PAColumbia, Maryland  21044
Chesapeake Oncology Hematology Associates (Tate Center)Glen Burnie, Maryland  21061
Josephine Ford Cancer Center -- DownriverBrownstown, Michigan  48183
Michael McKenzie, DOClinton Township, Michigan  48038
Henry Ford Medical Center -- FairlaneDearborn, Michigan  48126
Youssef Hanna, MDPort Huron, Michigan  48060
Cancer and Transplant Consultants, PLCRochester Hills, Michigan  48307
Cancer Care AssociatesRochester Hills, Michigan  48307
Cancer Care Associates, PCRoyal Oak, Michigan  48073
Hematology Oncology ConsultantsRoyal Oak, Michigan  48073
Jeffrey H. Margolis, MDRoyal Oak, Michigan  48073
Michigan Hematology and Oncology InstituteSouthgate, Michigan  48195
George A. Zervos, MDGlen Head, New York  11545
Northwestern Carolina Oncology HematologyHickory, North Carolina  28602
Dayton Hematology and OncologyKettering, Ohio  45409
Mukesh C. Bhatt, MDMedina, Ohio  44256
Northwest Cancer Specialists, NorthrupPortland, Oregon  97210
Shatish A. Shah, MDGettysburg, Pennsylvania  17325
Rittenhouse Hematology Oncology AssociatesPhiladelphia, Pennsylvania  19146
Chester County Hematology / Oncology ServicesWest Chester, Pennsylvania  19380
Palmetto Hematology Oncology, PCSpartanburg, South Carolina  29303-3041
Texas Cancer Center (Dallas Southwest)Dallas, Texas  75237
Texas Cancer Center / DentonDenton, Texas  76210
US Oncology Research and Clinical PharmacyFt. Worth, Texas  76177
Texas Oncology Cancer Center--Sugar LandSugar Land, Texas  77479
Annandale-Fairfax Virginia Hematology Oncology, PCFairfax, Virginia  22031
Masoom Kandahari, MD, PCWoodbridge, Virginia  22191
Jay L. Wittenkeller, MDSpokane, Washington  99204