Last updated: 07/18/2020 12:11:22

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

GSK study ID
104864/615
See study documents
Clinicaltrials.gov ID
NCT00065182
See results summary
EudraCT ID
2004-002892-17
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Median time of overall survival

Timeframe: Up to one year from Day -1 (randomization)

Secondary outcomes:

Number of participants with one-year survival

Timeframe: Up to one year from Day -1 (randomization)

Median time to progression

Timeframe: Up to one year from Day -1 (randomization)

Response rate

Timeframe: Up to one year from Day -1 (randomization)

Response duration

Timeframe: Up to one year from Day -1 (randomization)

Time to response-assessed every 8 weeks

Timeframe: Every 8 Weeks post randomization

Assessment of Quality of life-assessed every 4 weeks

Timeframe: Every 4 Weeks post randomization

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to 16 months

Number of participants with Grade 1, 2, 3 or 4 hematologic toxicities

Timeframe: Up to 16 months

Number of participants with Grade 3 or 4 clinical chemical toxicities

Timeframe: Up to 16 months

Number of participants with clinically significant abnormal vital signs data

Timeframe: Up to 16 months

Interventions:
Drug: Topotecan/Docetaxel combination
Drug: Docetaxel
Enrollment:
399
Observational study model:
Not applicable
Primary completion date:
2007-30-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
August 2003 to August 2007
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Written informed consent
  • At least 18 years old
  • Concomitant malignancies or other malignancies within the last five years.
  • Symptoms of brain metastases requiring treatment with steroids.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Kielce, Poland, 25-640
Status
Study Complete
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Location
GSK Investigational Site
Poznan, Poland, 60-569
Status
Study Complete
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Location
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
Status
Study Complete
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Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Study Complete
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Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Sainte-Foy, Québec, Canada, G1V 4G5
Status
Study Complete
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Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
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Location
GSK Investigational Site
Dunmore, Pennsylvania, United States, 18512
Status
Study Complete
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Location
GSK Investigational Site
Denver, Colorado, United States, 80210
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
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Location
GSK Investigational Site
Tyler, Texas, United States, 75701
Status
Study Complete
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Location
GSK Investigational Site
Orange Park, Florida, United States, 32073
Status
Study Complete
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Location
GSK Investigational Site
Lakeland, Florida, United States, 33805
Status
Study Complete
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
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Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
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Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19114
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
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Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70506
Status
Study Complete
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Location
GSK Investigational Site
Szczecin Zdunowo 20, Poland, 70-891
Status
Study Complete
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Location
GSK Investigational Site
London, Ontario, Canada, N6A 4L6
Status
Study Complete
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Location
GSK Investigational Site
Louisville, Kentucky, United States, 40207
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Decatur, Illinois, United States, 62526
Status
Study Complete
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Location
GSK Investigational Site
Columbus, Georgia, United States, 31902
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Orlando, Florida, United States, 32804
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Los Angeles, California, United States, 90067
Status
Study Complete
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Location
GSK Investigational Site
Hilton Head Island, South Carolina, United States, 29926
Status
Study Complete
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Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
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Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1C 8X3
Status
Study Complete
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Location
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
Status
Study Complete
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Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
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Location
GSK Investigational Site
Stuart, Florida, United States, 34994
Status
Study Complete
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Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407-3799
Status
Study Complete
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Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Status
Study Complete
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Location
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1C4
Status
Study Complete
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Location
GSK Investigational Site
Rochester, New York, United States, 14623
Status
Study Complete
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Location
GSK Investigational Site
Lake Charles, Louisiana, United States, 70601
Status
Study Complete
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Location
GSK Investigational Site
Washington, District of Columbia, United States, 20422
Status
Study Complete
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Location
GSK Investigational Site
Olsztyn, Poland, 10-228
Status
Study Complete
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Location
GSK Investigational Site
Kingston, Ontario, Canada, K7L 5P9
Status
Study Complete
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Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Irving, Texas, United States, 75038
Status
Study Complete
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Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
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Location
GSK Investigational Site
Grosse Point Woods, Michigan, United States, 48236
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Urbana, Illinois, United States, 61801
Status
Study Complete
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Location
GSK Investigational Site
Columbia, South Carolina, United States, 29203
Status
Study Complete
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Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
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Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
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Location
GSK Investigational Site
Skokie, Illinois, United States, 60077
Status
Study Complete
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Location
GSK Investigational Site
Reno, Nevada, United States, 89502
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Study Complete
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Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
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Location
GSK Investigational Site
Sheboygan, Wisconsin, United States, 53081
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Study Complete
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Location
GSK Investigational Site
Levis, Québec, Canada, G6V 3Z1
Status
Study Complete
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Location
GSK Investigational Site
Boca Raton, Florida, United States, 33428
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Bronx, New York, United States, 10467
Status
Study Complete
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Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1X5
Status
Study Complete
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Location
GSK Investigational Site
Bowling Green, Kentucky, United States, 42101
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
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Location
GSK Investigational Site
Washington, District of Columbia, United States, 20307-5001
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
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Location
GSK Investigational Site
St. Catharines, Ontario, Canada, L2R 5K3
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Weston, Ontario, Canada, M9N 1N8
Status
Study Complete
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Location
GSK Investigational Site
Fayetteville, North Carolina, United States, 28302-2000
Status
Study Complete
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Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
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Location
GSK Investigational Site
Krakow, Poland, 31-115
Status
Study Complete
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Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
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Location
GSK Investigational Site
Abingdon, Virginia, United States, 24211
Status
Study Complete
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Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
Status
Study Complete
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Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Study Complete
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Location
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N2
Status
Study Complete
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Location
GSK Investigational Site
Mobile, Alabama, United States, 36608
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Casper, Wyoming, United States, 85601
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Nyack, New York, United States, 10960
Status
Study Complete
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Location
GSK Investigational Site
Canton, Ohio, United States, 44718
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53295
Status
Study Complete
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Location
GSK Investigational Site
Frederick, Maryland, United States, 21701
Status
Study Complete
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Location
GSK Investigational Site
Kitchener, Ontario, Canada, N2G 1G3
Status
Study Complete
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Location
GSK Investigational Site
New Hyde Park, New York, United States, 11040
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Miami Shores, Florida, United States, 33138
Status
Study Complete
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Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
Status
Study Complete
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Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
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Location
GSK Investigational Site
Hackensack, New Jersey, United States, 07601
Status
Study Complete
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Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
Status
Terminated/Withdrawn
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2007-30-08
Actual study completion date
2007-30-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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Access to clinical trial data by researchers
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