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Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 17, 2003
Last updated: April 13, 2015
Last verified: April 2015
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Condition Intervention Phase
Non-Small-Cell Lung Cancer
Lung Cancer, Non-Small Cell
Drug: Topotecan/Docetaxel combination
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall survival - defined as the time from randomization to death. Occurs when all randomized subjects had at least one year of follow-up past their date of randomization to treatment.

Secondary Outcome Measures:
  • One-year survival; Time to progression; Response rate; Response duration; Time to response-assessed every 8 weeks;Quality of life-assessed every 4 weeks;Safety-weekly

Estimated Enrollment: 408
Study Start Date: August 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topotecan/Docetaxel combination Drug: Docetaxel
    Other Name: Topotecan/Docetaxel combination

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Written informed consent
  • At least 18 years old
  • Confirmed advanced non-small cell lung carcinoma (NSCLC)
  • Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
  • Presence of either measurable or non-measurable disease by radiologic study or physical examination.
  • Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
  • At least 7 days since prior radiotherapy.
  • A probable life expectance of at least 3 months.
  • Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

  • Concomitant malignancies or other malignancies within the last five years.
  • Symptoms of brain metastases requiring treatment with steroids.
  • Active infection.
  • Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
  • Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
  • Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
  • Women who are pregnant or lactating.
  • Subjects of child-bearing potential refusing to practice adequate contraception.
  • Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
  • Subjects who cannot receive steroid premedication.
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Please refer to this study by its identifier: NCT00065182

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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35801
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Fresno, California, United States, 93720
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Los Angeles, California, United States, 90067
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Poway, California, United States, 92064
United States, Colorado
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Denver, Colorado, United States, 80210
United States, District of Columbia
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Washington, District of Columbia, United States, 20422
United States, Florida
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Boca Raton, Florida, United States, 33428
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Boca Raton, Florida, United States, 33486
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Lakeland, Florida, United States, 33805
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Miami Shores, Florida, United States, 33138
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Orange Park, Florida, United States, 32073
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Orlando, Florida, United States, 32804
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Stuart, Florida, United States, 34994
United States, Georgia
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Columbus, Georgia, United States, 31902
United States, Illinois
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Decatur, Illinois, United States, 62526
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
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Skokie, Illinois, United States, 60077
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Urbana, Illinois, United States, 61801
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Kentucky
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Louisville, Kentucky, United States, 40207
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Louisville, Kentucky, United States, 40215
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Lafayette, Louisiana, United States, 70506
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Lake Charles, Louisiana, United States, 70601
United States, Maryland
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Frederick, Maryland, United States, 21701
United States, Massachusetts
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Boston, Massachusetts, United States, 02118
United States, Michigan
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Grosse Point Woods, Michigan, United States, 48236
United States, Minnesota
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Minneapolis, Minnesota, United States, 55407-3799
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Minneapolis, Minnesota, United States, 55417
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Robbinsdale, Minnesota, United States, 55422
United States, Missouri
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Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63141
United States, Nevada
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Las Vegas, Nevada, United States, 89106
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Reno, Nevada, United States, 89502
United States, New Jersey
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Hackensack, New Jersey, United States, 07601
United States, New York
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Bronx, New York, United States, 10467
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
GSK Investigational Site
East Syracuse, New York, United States, 13057
GSK Investigational Site
Manhasset, New York, United States, 11030
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New Hyde Park, New York, United States, 11040
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Nyack, New York, United States, 10960
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Rochester, New York, United States, 14623
United States, North Carolina
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Fayetteville, North Carolina, United States, 28302-2000
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Canton, Ohio, United States, 44718
United States, Pennsylvania
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Dunmore, Pennsylvania, United States, 18512
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Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
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Columbia, South Carolina, United States, 29203
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Hilton Head Island, South Carolina, United States, 29926
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Spartanburg, South Carolina, United States, 29303
United States, Tennessee
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Knoxville, Tennessee, United States, 37916
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Nashville, Tennessee, United States, 37203
United States, Texas
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Irving, Texas, United States, 75038
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Tyler, Texas, United States, 75701
United States, Virginia
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Abingdon, Virginia, United States, 24211
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Norfolk, Virginia, United States, 23507
United States, Washington
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Spokane, Washington, United States, 99204
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Tacoma, Washington, United States, 98405
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53295
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Sheboygan, Wisconsin, United States, 53081
United States, Wyoming
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Casper, Wyoming, United States, 85601
Canada, Alberta
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Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
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Kingston, Ontario, Canada, K7L 5P9
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1G3
GSK Investigational Site
London, Ontario, Canada, N6A 4L6
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1C4
GSK Investigational Site
St. Catharines, Ontario, Canada, L2R 5K3
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1X5
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Toronto, Ontario, Canada, M5G 2M9
GSK Investigational Site
Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Levis, Quebec, Canada, G6V 3Z1
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Sainte-Foy, Quebec, Canada, G1V 4G5
GSK Investigational Site
Kielce, Poland, 25-640
GSK Investigational Site
Poznan, Poland, 60-569
GSK Investigational Site
Szczecin Zdunowo 20, Poland, 70-891
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00065182     History of Changes
Other Study ID Numbers: 104864/615
Study First Received: July 17, 2003
Last Updated: April 13, 2015

Keywords provided by GlaxoSmithKline:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 25, 2017