Clinical trial NCT01500720: Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-28
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization to date of death (maximum 15 months)
measure: Progression Free Rate at Week 12
timeFrame: Week 12
measure: Overall Objective Tumor Response Rate
timeFrame: Randomization to disease progression/occurrence (maximum 7.6 months)
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Investigational Site Number 840007
state: Alabama
city: Omaha
country: United States
facility: Investigational Site Number 840005
state: Nebraska
city: Lebanon
country: United States
facility: Investigational Site Number 840006
state: New Hampshire
city: Middletown
country: United States
facility: Investigational Site Number 840003
state: Ohio
city: Philadelphia
country: United States
facility: Investigational Site Number 840001
state: Pennsylvania
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076001
city: Montreal
country: Canada
facility: Investigational Site Number 124003
city: Oshawa
country: Canada
facility: Investigational Site Number 124002
city: Rimouski
country: Canada
facility: Investigational Site Number 124004
city: Toronto
country: Canada
facility: Investigational Site Number 124001
city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
facility: Investigational Site Number 152005
city: Brest
country: France
facility: Investigational Site Number 250005
city: Caen Cedex
country: France
facility: Investigational Site Number 250004
city: La Tronche
country: France
facility: Investigational Site Number 250006
city: Lille
country: France
facility: Investigational Site Number 250002
city: Saint-Herblain Cedex
country: France
facility: Investigational Site Number 250003
city: Villejuif Cedex
country: France
facility: Investigational Site Number 250007
city: Großhansdorf
country: Germany
facility: Investigational Site Number 276003
city: Löwenstein
country: Germany
facility: Investigational Site Number 276006
city: Athens
country: Greece
facility: Investigational Site Number 300005
city: Athens
country: Greece
facility: Investigational Site Number 300003
city: Heraklion
country: Greece
facility: Investigational Site Number 300001
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300002
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300004
city: Budapest
country: Hungary
facility: Investigational Site Number 348001
city: Budapest
country: Hungary
facility: Investigational Site Number 348004
city: Budapest
country: Hungary
facility: Investigational Site Number 348002
city: Törökbálint
country: Hungary
facility: Investigational Site Number 348003
city: Genova
country: Italy
facility: Investigational Site Number 380001
city: Livorno
country: Italy
facility: Investigational Site Number 380002
city: Novara
country: Italy
facility: Investigational Site Number 380005
city: Parma
country: Italy
facility: Investigational Site Number 380004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Oslo
country: Norway
facility: Investigational Site Number 578001
city: Stavanger
country: Norway
facility: Investigational Site Number 578003
city: Trondheim
country: Norway
facility: Investigational Site Number 578002
city: Gdansk
country: Poland
facility: Investigational Site Number 616004
city: Lublin
country: Poland
facility: Investigational Site Number 616003
city: Poznan
country: Poland
facility: Investigational Site Number 616002
city: Warszawa
country: Poland
facility: Investigational Site Number 616001
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642003
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number 642005
city: Craiova
country: Romania
facility: Investigational Site Number 642001
city: Timisoara
country: Romania
facility: Investigational Site Number 642002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643005
city: Tula
country: Russian Federation
facility: Investigational Site Number 643006
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643003
city: Badalona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724004
city: Málaga
country: Spain
facility: Investigational Site Number 724005
city: Valencia
country: Spain
facility: Investigational Site Number 724001
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 804002
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804004
city: Lviv
country: Ukraine
facility: Investigational Site Number 804001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Beaumont H, Evans TL, Klifa C, Guermazi A, Hong SR, Chadjaa M, Monostori Z. Discrepancies of assessments in a RECIST 1.1 phase II clinical trial - association between adjudication rate and variability in images and tumors selection. Cancer Imaging. 2018 Dec 11;18(1):50. doi: 10.1186/s40644-018-0186-0.
citation: Evans TL, Cho BC, Udud K, Fischer JR, Shepherd FA, Martinez P, Ramlau R, Syrigos KN, Shen L, Chadjaa M, Wolf M. Cabazitaxel Versus Topotecan in Patients with Small-Cell Lung Cancer with Progressive Disease During or After First-Line Platinum-Based Chemotherapy. J Thorac Oncol. 2015 Aug;10(8):1221-8. doi: 10.1097/JTO.0000000000000588.