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Phase 3
18 Years
Not Enrolling
Carcinoma, Non-Small Cell Lung

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Trial Information

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

- 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


- 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:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

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



William Beaumont Hospital Royal Oak, Michigan  48073
Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Ocala Oncology Center Ocala, Florida  34474
Oncology/Hematology Care, Inc. Cincinnati, Ohio  45219
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Mary Crowley Medical Research Center Dallas, Texas  75246
Medical Oncology, LLC Baton Rouge, Louisiana  70808
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085
Cancer Care Associates Tulsa, Oklahoma  74136
St. Joseph Oncology, Inc. Saint Joseph, Missouri  64506
Henry Ford Health System Detroit, Michigan  48202
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
University of Chicago Chicago, Illinois  60637
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
Gabrail Cancer Center Canton, Ohio  44718
Texas Oncology, PA Dallas, Texas  75246-2006
Medical Oncology Associates of Wyoming Valley, PC Kingston, Pennsylvania  18704
Allison Cancer Center Midland, Texas  79701
West Texas Cancer Center Odessa, Texas  79761
Peninsula Cancer Institute Newport News, Virginia  23601
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Mile High Oncology Denver, Colorado  80210
Hematology Oncology Associates Phoenix, Arizona  85012
Arch Medical Services, INC. St. Louis, Missouri  63142
Cancer Center of Florida Ocoee, Florida  34761
Indiana Hematology Oncology Consultants Indianapolis, Indiana  46202
Texas Cancer Center Abilene, Texas  79606
Texas Oncology Cancer Center Austin, Texas  78731
El Paso Cancer Treatment Center El Paso, Texas  79915
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Cancer Care Institute of Carolina Aiken, South Carolina  29801
Billings Clinic Billings, Montana  59107-7000
Cancer Care Northwest Research Spokane, Washington  99218
New York Oncology Hematology, PC Albany, New York  12208
Puget Sound Cancer Centers Edmonds, Washington  98026
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Northern Indiana Oncology Associates South Bend, Indiana  46617
Mitchell Folbe, MD, PC Troy, Michigan  48085
Paris Regional Cancer Center Paris, Texas  75460
Oncology & Hematology Associates of Southwest Virginia, Inc. Salem, Virginia  24153
Citrus Hematology and Oncology Center Inverness, Florida  34452
Charleston Hematology Oncology, PA Charleston, South Carolina  29403
Henry Ford Medical Center Dearborn, Michigan  48126
Cancer and Blood Disease Center Lecanto, Florida  34461
Trilogy Cancer Center Wooster, Ohio  44691
Joliet Oncology Hematology Associates Joliet, Illinois  60435
Pasco Hernando Oncology Associates, PA New Port Richey, Florida  34642
Medical Specialists of Fairfield Fairfield, Connecticut  
Marshall Schreeder, MD Huntsville, Alabama  35801
James P. Daugherty, MD Muscle Shoals, Alabama  35661
Alaska Cancer Research Anchorage, Alaska  99508
Veena Charu, MD Anaheim, California  92801
Lalita Pandit, MD, Inc Fountain Valley, California  92708
Robert A. Moss, MD, FACP, Inc. Fountain Valley, California  92708
Warren Paroly, MD Oceanside, California  92056
Swarna S. Chanduri, MD Pomona, California  91767
Southwest Cancer Care Medical Group Poway, California  92064-2527
Pasco Hernando Oncology Associates PA Brooksville, Florida  34613
Lucio Gordan, MD Gainesville, Florida  32605
Nature Coast Clinical Research, LLC Inverness, Florida  34452
Jorge G. Otoya, MD Kissimmee, Florida  34741
Kansas City Cancer Centers, Southwest Overland Park, Kansas  66210
Maryland Oncology Hematology, PA Columbia, Maryland  21044
Chesapeake Oncology Hematology Associates (Tate Center) Glen Burnie, Maryland  21061
Josephine Ford Cancer Center -- Downriver Brownstown, Michigan  48183
Michael McKenzie, DO Clinton Township, Michigan  48038
Henry Ford Medical Center -- Fairlane Dearborn, Michigan  48126
Youssef Hanna, MD Port Huron, Michigan  48060
Cancer and Transplant Consultants, PLC Rochester Hills, Michigan  48307
Cancer Care Associates Rochester Hills, Michigan  48307
Cancer Care Associates, PC Royal Oak, Michigan  48073
Hematology Oncology Consultants Royal Oak, Michigan  48073
Jeffrey H. Margolis, MD Royal Oak, Michigan  48073
Michigan Hematology and Oncology Institute Southgate, Michigan  48195
George A. Zervos, MD Glen Head, New York  11545
Northwestern Carolina Oncology Hematology Hickory, North Carolina  28602
Dayton Hematology and Oncology Kettering, Ohio  45409
Mukesh C. Bhatt, MD Medina, Ohio  44256
Northwest Cancer Specialists, Northrup Portland, Oregon  97210
Shatish A. Shah, MD Gettysburg, Pennsylvania  17325
Rittenhouse Hematology Oncology Associates Philadelphia, Pennsylvania  19146
Chester County Hematology / Oncology Services West Chester, Pennsylvania  19380
Palmetto Hematology Oncology, PC Spartanburg, South Carolina  29303-3041
Texas Cancer Center (Dallas Southwest) Dallas, Texas  75237
Texas Cancer Center / Denton Denton, Texas  76210
US Oncology Research and Clinical Pharmacy Ft. Worth, Texas  76177
Texas Oncology Cancer Center--Sugar Land Sugar Land, Texas  77479
Annandale-Fairfax Virginia Hematology Oncology, PC Fairfax, Virginia  22031
Masoom Kandahari, MD, PC Woodbridge, Virginia  22191
Jay L. Wittenkeller, MD Spokane, Washington  99204