Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer, Non-Small CellNon-Small-Cell Lung Cancer
- Registration Number
- NCT00065182
- Lead Sponsor
- GlaxoSmithKline
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 399
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Median Time of Overall Survival Up to one year from Day -1 (randomization) Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.
- Secondary Outcome Measures
Name Time Method Number of Participants With One-year Survival Up to one year from Day -1 (randomization) Number of participants with one-year survival were planned to be reported.
Median Time to Progression Up to one year from Day -1 (randomization) Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.
Response Rate Up to one year from Day -1 (randomization) Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.
Response Duration Up to one year from Day -1 (randomization) Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.
Time to Response-assessed Every 8 Weeks Every 8 Weeks post randomization Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.
Assessment of Quality of Life-assessed Every 4 Weeks Every 4 Weeks post randomization The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 16 months AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.
Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities Up to 16 months Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.
Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities Up to 16 months Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.
Number of Participants With Clinically Significant Abnormal Vital Signs Data Up to 16 months Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇱Szczecin Zdunowo 20, Poland