Lung Cancer Clinical Trial
Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
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)
Full 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.
Eligibility Criteria
Inclusion criteria :
Histological/cytological proven locally advanced or metastatic small cell lung cancer with progressive disease during or after first line platinum based chemotherapy
Male or female greater than or equal to (>=) 18 years (or country's legal age of majority if greater than [>]18 years)
Participants with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 1
Exclusion criteria:
Absence of signed and dated Institutional Review Board (IRB)-approved participant informed consent form prior to enrollment into the study
More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes
Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or surgery to the time of randomization (Radiotherapy for bone pain palliation is allowed)
Adverse events (excluding alopecia) from any prior anticancer therapy of grade >1 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization
Uncontrolled Central Nervous System (CNS) metastases: participants with CNS metastases may have previous irradiation, only participants with stable disease or response to irradiation who are without CNS symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent could be included
Participants with known leptomeningeal metastases
History of other, invasive neoplasm requiring ongoing therapy
Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization
Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, stroke or transient ischemic attack
Any severe acute or chronic medical condition, which could impair the ability of the participant to participate in the study or interfere with interpretation of study results
Known Human Immunodeficiency Virus (HIV) disease, or active hepatitis B or C (systematic testing was not required)
Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization
Participant with reproductive potential (M/F) who did not agree to use an accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of "effective method of contraception" was based on the investigator's judgment. Effective method of contraception should also be adapted to local regulation
History of hypersensitivity to polysorbate 80
Inadequate organ and bone marrow function as evidenced by:
Hemoglobin less than [<] 9.0 gram per deciliter (g/dL)
Absolute neutrophil count <1.5 x 10^9 per liter
Platelet count <100 x 10^9 per liter
Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) and/or alanine aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) >2.5 x Upper Limit of Normal (ULN)
Alkaline Phosphatase (AP) >2.5 x ULN. In case of liver metastases AP >5 x ULN
Total bilirubin >1.0 x ULN
Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Collaboration formula, and creatinine clearance <60 milliliter per minute (mL/min) was exclude the participant.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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There are 54 Locations for this study
Muscle Shoals Alabama, 35661, United States
Omaha Nebraska, 68114, United States
Lebanon New Hampshire, 03756, United States
Middletown Ohio, 45042, United States
Philadelphia Pennsylvania, 19104, United States
Porto Alegre , 90610, Brazil
Montreal , H3T 1, Canada
Oshawa , L1G 2, Canada
Rimouski , G5L 5, Canada
Toronto , M5G 2, Canada
Santiago , 83804, Chile
Santiago , , Chile
Brest , 29609, France
Caen Cedex , 14033, France
La Tronche , 38700, France
Lille , 59800, France
Saint-Herblain Cedex , 44805, France
Villejuif Cedex , 94805, France
Großhansdorf , 22927, Germany
Löwenstein , 74245, Germany
Athens , 11522, Greece
Athens , 11527, Greece
Heraklion , 71110, Greece
Thessaloniki , 54629, Greece
Thessaloniki , 57010, Greece
Budapest , 1121, Hungary
Budapest , 1121, Hungary
Budapest , 1125, Hungary
Törökbálint , 2045, Hungary
Genova , 16132, Italy
Livorno , 57123, Italy
Novara , 28100, Italy
Parma , 43100, Italy
Seoul , 120-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Oslo , 0440, Norway
Stavanger , 4011, Norway
Trondheim , 7006, Norway
Gdansk , 80-95, Poland
Lublin , 20-95, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Cluj Napoca , 40001, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20038, Romania
Timisoara , , Romania
Moscow , 11547, Russian Federation
St-Petersburg , 19775, Russian Federation
Tula , 30005, Russian Federation
Yaroslavl , 15005, Russian Federation
Badalona , 08916, Spain
Barcelona , 08035, Spain
Málaga , 29010, Spain
Valencia , 46026, Spain
Dnipropetrovsk , 49102, Ukraine
Donetsk , 83092, Ukraine
Lviv , 70031, Ukraine
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