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

Completed · Phase 2

Conditions studied: Lung Cancer, Non-Small Cell, Non-Small-Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00065182

Run by

GlaxoSmithKline

People needed

399

Starts

2003-08-14

Expected to finish

2007-08-30

Last updated by the study team

2019-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Poway, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Lakeland, Florida, United States
• GSK Investigational Site — Miami Shores, Florida, United States
• GSK Investigational Site — Orange Park, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Stuart, Florida, United States
• GSK Investigational Site — Columbus, Georgia, United States
• GSK Investigational Site — Decatur, Illinois, United States
• GSK Investigational Site — Elk Grove Village, Illinois, United States
• GSK Investigational Site — Skokie, Illinois, United States
• GSK Investigational Site — Urbana, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Bowling Green, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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