The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Gemcitabine/Oxaliplatin (GEMOX)  Drug: Carboplatin/Paclitaxel (CP)	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
• One (1) unidimensionally measurable lesion
• ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1
• Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
• Recovery in full from any previous surgical procedure
• No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease

Exclusion Criteria:

• Hypersensitivity to any of the 4 study drugs
• Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
• Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
• History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
• Patient is a pregnant or lactating female

Stephanie Mull      832-601-6475    stephanie.mull@usoncology.com
Sharon Pritchard      214-584-3217    sharon.pritchard@usoncology.com

Alabama
      Birmingham Hematology and Oncology Associates, Birmingham,  Alabama,  35235,  United States; Recruiting
      Birmingham Hematology and Oncology Associates, LLC, Birmingham,  Alabama,  35235,  United States; Recruiting
Arizona
      Arizona Oncology Associates - Hematology Oncology Physicians, Tucson,  Arizona,  85704,  United States; Recruiting
      Northern Arizona Hematology & Oncology Associates, Sedona,  Arizona,  86336,  United States; Recruiting
      Hematology Oncology Associates, Phoenix,  Arizona,  85012,  United States; Recruiting
Colorado
      Rocky Mountain Cancer Centers, Denver,  Colorado,  80218,  United States; Recruiting
Florida
      South Florida Oncology & Hematology Consultants, Plantation,  Florida,  33324,  United States; Recruiting
      Cancer Centers of Florida, P.A., Ocoee,  Florida,  34761,  United States; Recruiting
      Ocala Oncology Center, Ocala,  Florida,  34474,  United States; Recruiting
      Florida Cancer Institute, New Port Richey,  Florida,  34652,  United States; Recruiting
Illinois
      Hematology Oncology Associates of Illinois, Skokie,  Illinois,  60077,  United States; Recruiting
      Northwest Medical Specialists, PC, Niles,  Illinois,  60714,  United States; Recruiting
      Hematology Oncology Associates of Illinois, Chicago,  Illinois,  60611,  United States; Recruiting
Indiana
      Central Indiana Cancer Centers, Indianapolis,  Indiana,  46227,  United States; Recruiting
Iowa
      Oncology Associates of Cedar Rapids, Cedar Rapids,  Iowa,  52403,  United States; Recruiting
Kansas
      Kansas City Oncology and Hematology Group, Overland Park,  Kansas,  66210,  United States; Recruiting
Maryland
      Maryland Oncology Hematology, P.A., Columbia,  Maryland,  21044,  United States; Recruiting
Massachusetts
      Berkshire Hematology Oncology, PC, Pittsfield,  Massachusetts,  01201,  United States; Recruiting
Minnesota
      Minnesota Oncology Hematology, Minneapolis,  Minnesota,  55404,  United States; Recruiting
      Minnesota Oncology Hematology, P.A., Minneapolis,  Minnesota,  55404,  United States; Recruiting
Missouri
      Arch Medical Services, Inc., St. Louis,  Missouri,  63141,  United States; Recruiting
      Missouri Cancer Associates, Columbia,  Missouri,  65201,  United States; Recruiting
Nevada
      Comprehensive Cancer Centers of Nevada, Las Vegas,  Nevada,  89109,  United States; Recruiting
New Mexico
      New Mexico Cancer Care Associates, Santa Fe,  New Mexico,  87505,  United States; Recruiting
New York
      New York Oncology Hematology, Latham,  New York,  12110,  United States; Recruiting
      New York Oncology Hematology, P.C., Albany,  New York,  12208,  United States; Recruiting
      Interlakes Oncology & Hematology, P.C., Rochester,  New York,  14623,  United States; Recruiting
      New York Oncology Hematology, P.C., Rexford,  New York,  12148,  United States; Recruiting
North Carolina
      Raleigh Hematology Oncology Clinic, Cary,  North Carolina,  27511,  United States; Recruiting
      Piedmont Hematology Oncology Associates, PLLC., Winston Salem,  North Carolina,  27103,  United States; Recruiting
Ohio
      Dayton Oncology & Hematology, P.A., Kettering,  Ohio,  45409,  United States; Recruiting
Oklahoma
      Cancer Care Associates, Tulsa,  Oklahoma,  74136-1902,  United States; Recruiting
      Cancer Care Associates, Oklahoma City,  Oklahoma,  73120,  United States; Recruiting
Oregon
      Willamette Valley Cancer Center, Eugene,  Oregon,  97401,  United States; Recruiting
South Carolina
      Cancer Centers of the Carolinas, Seneca,  South Carolina,  29672,  United States; Recruiting
Texas
      The Texas Cancer Center, Dallas,  Texas,  75237,  United States; Recruiting
      Texas Oncology, P.A., Dallas,  Texas,  75246,  United States; Recruiting
      Texas Oncology, P.A., Dallas,  Texas,  75231,  United States; Recruiting
      Texas Cancer Center at Medical City, Dallas,  Texas,  75230-2510,  United States; Recruiting
      Texas Oncology, P.A., Bedford,  Texas,  76022,  United States; Recruiting
      Mamie McFaddin Ward Cancer Center, Beaumont,  Texas,  77702-1449,  United States; Recruiting
      Texas Oncology Cancer Center, Austin,  Texas,  78731,  United States; Recruiting
      Texas Oncology, P.A., Arlington,  Texas,  76012,  United States; Recruiting
      Texas Cancer Center - Abilene, Abilene,  Texas,  79606,  United States; Recruiting
      Texas Cancer Center of Mesquite, Mesquite,  Texas,  75150,  United States; Recruiting
      South Texas Cancer Center - McAllen, McAllen,  Texas,  78503-1298,  United States; Recruiting
      Longview Cancer Center, Longview,  Texas,  75601,  United States; Recruiting
      Lake Vista Cancer Center, Lewisville,  Texas,  75067,  United States; Recruiting
      Texas Oncology, P.A., Irving,  Texas,  75061-2244,  United States; Recruiting
      Texas Oncology, P.A., Houston,  Texas,  77024,  United States; Recruiting
      Texas Oncology, P.A., Garland,  Texas,  75042-5788,  United States; Recruiting
      Texas Oncology, P.A., Fort Worth,  Texas,  76104,  United States; Recruiting
      El Paso Cancer Treatment Ctr-East, El Paso,  Texas,  79915,  United States; Recruiting
      Texas Cancer Center - Denton, Denton,  Texas,  76210,  United States; Recruiting
      Deke Slayton Cancer Center, Webster,  Texas,  77598,  United States; Recruiting
      Waco Cancer Care and Research Center, Waco,  Texas,  76712,  United States; Recruiting
      Tyler Cancer Center, Tyler,  Texas,  75702,  United States; Recruiting
      Texas Cancer Center - Sherman, Sherman,  Texas,  75090-0504,  United States; Recruiting
      San Antonio Tumor and Blood Clinic, Fredericksburg,  Texas,  78624,  United States; Recruiting
      Hematology Oncology Associates of South Texas, San Antonio,  Texas,  78229,  United States; Recruiting
      Paris Regional Cancer Center, Paris,  Texas,  75460,  United States; Recruiting
      West Texas Cancer Center, Odessa,  Texas,  79761,  United States; Recruiting
      Allison Cancer Center, Midland,  Texas,  79701-5946,  United States; Recruiting
Virginia
      Oncology & Hematology Associates of Southwest Virginia, Inc., Salem,  Virginia,  24153,  United States; Recruiting
      Virginia Oncology Associates, Norfolk,  Virginia,  23502,  United States; Recruiting
      Fairfax Northern Virginia Hematology Oncology, PC, Fairfax,  Virginia,  22031,  United States; Recruiting
Washington
      Northwest Cancer Specialists, P.C., Vancouver,  Washington,  98684,  United States; Recruiting
      Cancer Care Northwest, Spokane,  Washington,  99218,  United States; Recruiting
      Puget Sound Cancer Centers, Seattle,  Washington,  98133,  United States; Recruiting
      Puget Sound Cancer Centers, Edmonds,  Washington,  98026,  United States; Recruiting

Study ID Numbers:  L_9210; 03-095
Record last reviewed:  July 2004
Record first received:  July 13, 2004
ClinicalTrials.gov Identifier:  NCT00087802
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10