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

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	Drug: Topotecan/Docetaxel combination Drug: Docetaxel	Phase II

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Docetaxel Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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)

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

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 81 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104864/615
First Received:	July 17, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00065182
Health Authority:	United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by GlaxoSmithKline:

HYCAMTIN

topotecan

docetaxel

TAXOTERE

non-small cell lung cancer

NSCLC

Advanced

Stage IIIB/IV

Study placed in the following topic categories:

Docetaxel

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Topotecan

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00065182