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

NCT ID: NCT00065182

Last Updated: 2019-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-14

Study Completion Date

2007-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan/Docetaxel combination

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Other Intervention Names

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Topotecan/Docetaxel combination

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Poway, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Boca Raton, Florida, United States

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Lakeland, Florida, United States

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Miami Shores, Florida, United States

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Orange Park, Florida, United States

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Orlando, Florida, United States

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Stuart, Florida, United States

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Columbus, Georgia, United States

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Decatur, Illinois, United States

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Elk Grove Village, Illinois, United States

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Skokie, Illinois, United States

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Urbana, Illinois, United States

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Indianapolis, Indiana, United States

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Bowling Green, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Lafayette, Louisiana, United States

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Lake Charles, Louisiana, United States

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Frederick, Maryland, United States

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Boston, Massachusetts, United States

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Grosse Pointe Woods, Michigan, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Hackensack, New Jersey, United States

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Buffalo, New York, United States

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East Syracuse, New York, United States

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Manhasset, New York, United States

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New Hyde Park, New York, United States

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Nyack, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Fayetteville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Dunmore, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Hilton Head Island, South Carolina, United States

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Spartanburg, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Irving, Texas, United States

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Tyler, Texas, United States

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Abingdon, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Sheboygan, Wisconsin, United States

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Casper, Wyoming, United States

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Calgary, Alberta, Canada

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Moncton, New Brunswick, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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St. Catharines, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Lévis, Quebec, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, Canada

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GSK Investigational Site

Kielce, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Olsztyn, , Poland

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GSK Investigational Site

Poznan, , Poland

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GSK Investigational Site

Szczecin Zdunowo 20, , Poland

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Countries

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United States Canada Poland

Other Identifiers

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2004-002892-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

104864/615

Identifier Type: -

Identifier Source: org_study_id

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