Primary Objective: 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. Secondary Objectives: * 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)
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
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.
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.
Investigational Site Number 840007
Muscle Shoals, Alabama, United States
Investigational Site Number 840005
Omaha, Nebraska, United States
Investigational Site Number 840006
Lebanon, New Hampshire, United States
Investigational Site Number 840003
Middletown, Ohio, United States
Investigational Site Number 840001
Philadelphia, Pennsylvania, United States
Progression Free Survival (PFS)
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.
Time frame: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
Overall Survival
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.
Time frame: From randomization to date of death (maximum 15 months)
Progression Free Rate at 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.
Time frame: Week 12
Overall Objective Tumor Response Rate
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.
Time frame: Randomization to disease progression/occurrence (maximum 7.6 months)
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Investigational Site Number 076001
Porto Alegre, Brazil
Investigational Site Number 124003
Montreal, Canada
Investigational Site Number 124002
Oshawa, Canada
Investigational Site Number 124004
Rimouski, Canada
Investigational Site Number 124001
Toronto, Canada
...and 48 more locations