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Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer (NCT00003587)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different combination chemotherapy regimens in treating patients who have stage IIIB or stage IV non-small cell lung cancer
  • Drug: carboplatin
    AUC=5.5 day 1 every 21 days X 3
    • carbo
  • Drug: cisplatin
    IV cisplatin 100 mg/m^2 day 1 every 21 days X 3
    • platinol
  • Drug: docetaxel
    IV docetaxel 75 mg/m^2 day 1 every 21 days X 3
    • taxotere
  • Drug: gemcitabine
    IV gemcitabine 1,000 mg/m^2/day, days 1 and 8 every 21 days X3
    • gemzar
  • Drug: paclitaxel
    IV paclitaxel 225 mg/m^2/day, day 1 every 21 days X 3
    • taxol
  • Drug: vinorelbine
    IV vinorelbine 25 mg/m^2/day, days 1 and 8 every 21 days X 3
    • navelbine
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
OBJECTIVES: I. Assess the survival and failure free survival of patients with advanced primary non-small cell lung cancer treated with carboplatin and gemcitabine followed by paclitaxel OR cisplatin and vinorelbine followed by docetaxel. II. Evaluate the response (confirmed plus unconfirmed) and toxicities associated with these two regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of carboplatin and gemcitabine, patients receive paclitaxel IV over 3 hours on day 1 every 21 days for 3 courses. Arm II: Patients receive cisplatin IV over 30-60 minutes on day 1 followed by vinorelbine IV over 6-10 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Following the 3 courses of cisplatin and vinorelbine, patients receive docetaxel IV over 1 hour on day 1 every 21 days for 3 courses. Patients receive no further treatment until evidence of disease progression. Patients are followed every 2 months for the first year, every 6 months for years 2 and 3, and annually thereafter.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

84 locations

United States (84)
  • MBCCOP - University of South Alabama
    Not specified
    Mobile, Alabama, United States, 36688
  • CCOP - Greater Phoenix
    Not specified
    Phoenix, Arizona, United States, 85006-2726
  • Veterans Affairs Medical Center - Phoenix (Hayden)
    Not specified
    Phoenix, Arizona, United States, 85012
  • Veterans Affairs Medical Center - Tucson
    Not specified
    Tucson, Arizona, United States, 85723
  • Arizona Cancer Center
    Not specified
    Tucson, Arizona, United States, 85724
  • University of Arkansas for Medical Sciences
    Not specified
    Little Rock, Arkansas, United States, 72205
  • Veterans Affairs Medical Center - Little Rock (McClellan)
    Not specified
    Little Rock, Arkansas, United States, 72205
  • Beckman Research Institute, City of Hope
    Not specified
    Duarte, California, United States, 91010
  • Veterans Affairs Medical Center - Long Beach
    Not specified
    Long Beach, California, United States, 90822
  • USC/Norris Comprehensive Cancer Center
    Not specified
    Los Angeles, California, United States, 90033-0800
  • Jonsson Comprehensive Cancer Center, UCLA
    Not specified
    Los Angeles, California, United States, 90095-1781
  • Veterans Affairs Outpatient Clinic - Martinez
    Not specified
    Martinez, California, United States, 94553
  • CCOP - Bay Area Tumor Institute
    Not specified
    Oakland, California, United States, 94609-3305
  • University of California Davis Medical Center
    Not specified
    Sacramento, California, United States, 95817
  • UCSF Cancer Center and Cancer Research Institute
    Not specified
    San Francisco, California, United States, 94115-0128
  • CCOP - Santa Rosa Memorial Hospital
    Not specified
    Santa Rosa, California, United States, 95403
  • David Grant Medical Center
    Not specified
    Travis Air Force Base, California, United States, 94535
  • Veterans Affairs Medical Center - Denver
    Not specified
    Denver, Colorado, United States, 80220
  • University of Colorado Cancer Center
    Not specified
    Denver, Colorado, United States, 80262
  • CCOP - Atlanta Regional
    Not specified
    Atlanta, Georgia, United States, 30342-1701
  • Dwight David Eisenhower Army Medical Center
    Not specified
    Fort Gordon, Georgia, United States, 30905-5650
  • Cancer Research Center of Hawaii
    Not specified
    Honolulu, Hawaii, United States, 96813
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
    Not specified
    Hines, Illinois, United States, 60141
  • Loyola University Medical Center
    Not specified
    Maywood, Illinois, United States, 60153
  • CCOP - Central Illinois
    Not specified
    Springfield, Illinois, United States, 62526
  • University of Kansas Medical Center
    Not specified
    Kansas City, Kansas, United States, 66160-7357
  • CCOP - Wichita
    Not specified
    Wichita, Kansas, United States, 67214-3882
  • Veterans Affairs Medical Center - Wichita
    Not specified
    Wichita, Kansas, United States, 67218
  • Veterans Affairs Medical Center - Lexington
    Not specified
    Lexington, Kentucky, United States, 40511-1093
  • Albert B. Chandler Medical Center, University of Kentucky
    Not specified
    Lexington, Kentucky, United States, 40536-0084
  • MBCCOP - LSU Medical Center
    Not specified
    New Orleans, Louisiana, United States, 70112
  • Tulane University School of Medicine
    Not specified
    New Orleans, Louisiana, United States, 70112
  • Veterans Affairs Medical Center - New Orleans
    Not specified
    New Orleans, Louisiana, United States, 70112
  • Louisiana State University Hospital - Shreveport
    Not specified
    Shreveport, Louisiana, United States, 71130-3932
  • Veterans Affairs Medical Center - Shreveport
    Not specified
    Shreveport, Louisiana, United States, 71130
  • Boston Medical Center
    Not specified
    Boston, Massachusetts, United States, 02118
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    Not specified
    Jamaica Plain, Massachusetts, United States, 02130
  • Veterans Affairs Medical Center - Ann Arbor
    Not specified
    Ann Arbor, Michigan, United States, 48105
  • University of Michigan Comprehensive Cancer Center
    Not specified
    Ann Arbor, Michigan, United States, 48109-0752
  • Veterans Affairs Medical Center - Detroit
    Not specified
    Detroit, Michigan, United States, 48201-1932
  • Barbara Ann Karmanos Cancer Institute
    Not specified
    Detroit, Michigan, United States, 48201
  • Henry Ford Hospital
    Not specified
    Detroit, Michigan, United States, 48202
  • CCOP - Grand Rapids Clinical Oncology Program
    Not specified
    Grand Rapids, Michigan, United States, 49503
  • Providence Hospital - Southfield
    Not specified
    Southfield, Michigan, United States, 48075-9975
  • Veterans Affairs Medical Center - Biloxi
    Not specified
    Biloxi, Mississippi, United States, 39531-2410
  • University of Mississippi Medical Center
    Not specified
    Jackson, Mississippi, United States, 39216-4505
  • Veterans Affairs Medical Center - Jackson
    Not specified
    Jackson, Mississippi, United States, 39216
  • Keesler Medical Center - Keesler AFB
    Not specified
    Keesler AFB, Mississippi, United States, 39534-2576
  • Veterans Affairs Medical Center - Kansas City
    Not specified
    Kansas City, Missouri, United States, 64128
  • CCOP - Kansas City
    Not specified
    Kansas City, Missouri, United States, 64131
  • St. Louis University Health Sciences Center
    Not specified
    Saint Louis, Missouri, United States, 63110-0250
  • CCOP - St. Louis-Cape Girardeau
    Not specified
    Saint Louis, Missouri, United States, 63141
  • CCOP - Ozarks Regional
    Not specified
    Springfield, Missouri, United States, 65807
  • CCOP - Montana Cancer Consortium
    Not specified
    Billings, Montana, United States, 59101
  • Veterans Affairs Medical Center - Albuquerque
    Not specified
    Albuquerque, New Mexico, United States, 87108-5138
  • University of New Mexico Cancer Research & Treatment Center
    Not specified
    Albuquerque, New Mexico, United States, 87131
  • Veterans Affairs Medical Center - Brooklyn
    Not specified
    Brooklyn, New York, United States, 11209
  • Herbert Irving Comprehensive Cancer Center
    Not specified
    New York, New York, United States, 10032
  • Barrett Cancer Center, The University Hospital
    Not specified
    Cincinnati, Ohio, United States, 45219
  • Veterans Affairs Medical Center - Cincinnati
    Not specified
    Cincinnati, Ohio, United States, 45220-2288
  • Cleveland Clinic Cancer Center
    Not specified
    Cleveland, Ohio, United States, 44195
  • CCOP - Columbus
    Not specified
    Columbus, Ohio, United States, 43206
  • Veterans Affairs Medical Center - Dayton
    Not specified
    Dayton, Ohio, United States, 45428
  • CCOP - Dayton
    Not specified
    Kettering, Ohio, United States, 45429
  • Oklahoma Medical Research Foundation
    Not specified
    Oklahoma City, Oklahoma, United States, 73104
  • Veterans Affairs Medical Center - Oklahoma City
    Not specified
    Oklahoma City, Oklahoma, United States, 73104
  • Oregon Cancer Center at Oregon Health Sciences University
    Not specified
    Portland, Oregon, United States, 97201-3098
  • Veterans Affairs Medical Center - Portland
    Not specified
    Portland, Oregon, United States, 97207
  • CCOP - Columbia River Program
    Not specified
    Portland, Oregon, United States, 97213
  • CCOP - Greenville
    Not specified
    Greenville, South Carolina, United States, 29615
  • CCOP - Upstate Carolina
    Not specified
    Spartanburg, South Carolina, United States, 29303
  • Brooke Army Medical Center
    Not specified
    Fort Sam Houston, Texas, United States, 78234
  • University of Texas Medical Branch
    Not specified
    Galveston, Texas, United States, 77555-1329
  • Texas Tech University Health Science Center
    Not specified
    Lubbock, Texas, United States, 79423
  • University of Texas Health Science Center at San Antonio
    Not specified
    San Antonio, Texas, United States, 78284
  • Veterans Affairs Medical Center - San Antonio (Murphy)
    Not specified
    San Antonio, Texas, United States, 78284
  • Veterans Affairs Medical Center - Temple
    Not specified
    Temple, Texas, United States, 76504
  • CCOP - Scott and White Hospital
    Not specified
    Temple, Texas, United States, 76508
  • Huntsman Cancer Institute
    Not specified
    Salt Lake City, Utah, United States, 84132
  • Veterans Affairs Medical Center - Salt Lake City
    Not specified
    Salt Lake City, Utah, United States, 84148
  • CCOP - Virginia Mason Research Center
    Not specified
    Seattle, Washington, United States, 98101
  • Swedish Hospital Tumor Institute
    Not specified
    Seattle, Washington, United States, 98104
  • Veterans Affairs Medical Center - Seattle
    Not specified
    Seattle, Washington, United States, 98108
  • CCOP - Northwest
    Not specified
    Tacoma, Washington, United States, 98405-0986
Status:
completed
Type:
Interventional
Phase:
Start:
30 September, 1998
Updated:
04 October, 2012
Participants:
204
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