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

  Show 80 Study Locations
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 April 17, 2014