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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065182
Recruitment Status : Completed
First Posted : July 18, 2003
Last Update Posted : April 14, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Lung Cancer, Non-Small Cell Drug: Topotecan/Docetaxel combination Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: Topotecan/Docetaxel combination
  • Drug: Docetaxel
    Other Name: Topotecan/Docetaxel combination

Primary Outcome Measures :
  1. 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 :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065182

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Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00065182     History of Changes
Other Study ID Numbers: 104864/615
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 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