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

Tracking Information

First Received Date ^ICMJE

July 17, 2003

Last Updated Date

May 21, 2009

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Overall survival

Change History

Complete list of historical versions of study NCT00065182 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

One-year survival Time to progression Response rate Response duration Time to response Quality of life Safety and tolerability

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Small-Cell Lung Cancer

Intervention ^ICMJE

Drug: Topotecan/Docetaxel combination
Drug: Docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

408

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Poland

Administrative Information

NCT ID ^ICMJE

NCT00065182

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

104864/615

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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