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
Study complete
Study complete
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
    Primary completion date:
    2007-30-08
    Observational study model:
    Not applicable
    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
    Study complete
    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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