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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00065182
First received: July 17, 2003
Last updated: June 14, 2012
Last verified: June 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
Intervention Details:
    Drug: Topotecan/Docetaxel combination Drug: Docetaxel
    Other Names:
    • Docetaxel
    • Topotecan/Docetaxel combination
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065182

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00065182     History of Changes
Other Study ID Numbers: 104864/615
Study First Received: July 17, 2003
Last Updated: June 14, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Canadian Institutes of Health Research
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Stage IIIB/IV
topotecan
docetaxel
TAXOTERE
HYCAMTIN
non-small cell lung cancer
Advanced
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Topotecan
Docetaxel
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014