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

July 17, 2003
April 13, 2015
August 2003
August 2007   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00065182 on Archive Site
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
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Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
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)
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.
Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Small-Cell Lung Cancer
  • Lung Cancer, Non-Small Cell
  • Drug: Topotecan/Docetaxel combination
  • Drug: Docetaxel
    Other Name: Topotecan/Docetaxel combination
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2007
August 2007   (final data collection date for primary outcome measure)

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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Poland
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP