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: April 13, 2015
Last verified: April 2015
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:
| Study Completion Date:
| Primary Completion Date:
||August 2007 (Final data collection date for primary outcome measure)
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||April 13, 2015
||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 September 01, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors