Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
- Registration Number
- NCT01500720
- Lead Sponsor
- Sanofi
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cabazitaxel Cabazitaxel - Topotecan Topotecan -
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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.
- Secondary Outcome Measures
Name Time Method Overall Objective Tumor Response Rate 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.
Overall Survival 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 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.
Trial Locations
- Locations (58)
Investigational Site Number 642001
🇷🇴Craiova, Romania
Investigational Site Number 300005
🇬🇷Athens, Greece
Investigational Site Number 840006
🇺🇸Lebanon, New Hampshire, United States
Investigational Site Number 152005
🇨🇱Santiago, Chile
Investigational Site Number 840007
🇺🇸Muscle Shoals, Alabama, United States
Investigational Site Number 840005
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 124003
🇨🇦Montreal, Canada
Investigational Site Number 124002
🇨🇦Oshawa, Canada
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 124004
🇨🇦Rimouski, Canada
Investigational Site Number 124001
🇨🇦Toronto, Canada
Investigational Site Number 250005
🇫🇷Brest, France
Investigational Site Number 250006
🇫🇷La Tronche, France
Investigational Site Number 276006
🇩🇪Löwenstein, Germany
Investigational Site Number 250004
🇫🇷Caen Cedex, France
Investigational Site Number 250003
🇫🇷Saint-Herblain Cedex, France
Investigational Site Number 250007
🇫🇷Villejuif Cedex, France
Investigational Site Number 276003
🇩🇪Großhansdorf, Germany
Investigational Site Number 250002
🇫🇷Lille, France
Investigational Site Number 300003
🇬🇷Athens, Greece
Investigational Site Number 300001
🇬🇷Heraklion, Greece
Investigational Site Number 348004
🇭🇺Budapest, Hungary
Investigational Site Number 300002
🇬🇷Thessaloniki, Greece
Investigational Site Number 300004
🇬🇷Thessaloniki, Greece
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 380005
🇮🇹Novara, Italy
Investigational Site Number 348002
🇭🇺Budapest, Hungary
Investigational Site Number 348003
🇭🇺Törökbálint, Hungary
Investigational Site Number 380004
🇮🇹Parma, Italy
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 616003
🇵🇱Lublin, Poland
Investigational Site Number 410003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 578001
🇳🇴Oslo, Norway
Investigational Site Number 578003
🇳🇴Stavanger, Norway
Investigational Site Number 578002
🇳🇴Trondheim, Norway
Investigational Site Number 616004
🇵🇱Gdansk, Poland
Investigational Site Number 380001
🇮🇹Genova, Italy
Investigational Site Number 380002
🇮🇹Livorno, Italy
Investigational Site Number 840003
🇺🇸Middletown, Ohio, United States
Investigational Site Number 840001
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 642003
🇷🇴Cluj Napoca, Romania
Investigational Site Number 642002
🇷🇴Timisoara, Romania
Investigational Site Number 643005
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643006
🇷🇺Tula, Russian Federation
Investigational Site Number 643003
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 804002
🇺🇦Dnipropetrovsk, Ukraine
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 804001
🇺🇦Lviv, Ukraine
Investigational Site Number 724004
🇪🇸Barcelona, Spain
Investigational Site Number 616001
🇵🇱Warszawa, Poland
Investigational Site Number 642005
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 804004
🇺🇦Donetsk, Ukraine
Investigational Site Number 616002
🇵🇱Poznan, Poland
Investigational Site Number 724001
🇪🇸Valencia, Spain
Investigational Site Number 724002
🇪🇸Badalona, Spain
Investigational Site Number 076001
🇧🇷Porto Alegre, Brazil
Investigational Site Number 724005
🇪🇸Málaga, Spain