Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01500720|
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.
- To assess disease progression free rate at 12 weeks
- To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
- To assess Overall Survival (OS)
- To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
- To assess the Health-Related Quality of Life (HRQoL)
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Cabazitaxel Drug: Topotecan||Phase 2|
Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.
All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy|
|Study Start Date :||March 2012|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
Other Name: XRP6258
|Active Comparator: Topotecan||
Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
- Progression Free Survival (PFS) [ Time Frame: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months) ]PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
- Overall Survival [ Time Frame: From randomization to date of death (maximum 15 months) ]Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.
- Progression Free Rate at Week 12 [ Time Frame: Week 12 ]Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.
- Overall Objective Tumor Response Rate [ Time Frame: Randomization to disease progression/occurrence (maximum 7.6 months) ]Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500720
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|Study Director:||Clinical Sciences & Operations||Sanofi|