Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: July 17, 2003
Last updated: June 14, 2012
Last verified: June 2011
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.
Non-Small-Cell Lung Cancer
Lung Cancer, Non-Small Cell
Drug: Topotecan/Docetaxel combination
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
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:
| Study Start Date:
Drug: Topotecan/Docetaxel combination
- Topotecan/Docetaxel combination
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065182
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 17, 2003
||June 14, 2012
||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:
non-small cell lung cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Topoisomerase I Inhibitors
Molecular Mechanisms of Pharmacological Action