Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00065182|
Recruitment Status : Completed
First Posted : July 18, 2003
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer||Drug: Topotecan/Docetaxel combination Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||399 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL|
|Actual Study Start Date :||August 14, 2003|
|Actual Primary Completion Date :||August 30, 2007|
|Actual Study Completion Date :||August 30, 2007|
- Drug: Topotecan/Docetaxel combination
- Drug: Docetaxel
Other Name: Topotecan/Docetaxel combination
- Median Time of Overall Survival [ Time Frame: 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.
- Number of Participants With One-year Survival [ Time Frame: Up to one year from Day -1 (randomization) ]Number of participants with one-year survival were planned to be reported.
- Median Time to Progression [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065182
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|