Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

NCT ID: NCT01500720

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabazitaxel

Group Type: EXPERIMENTAL

Cabazitaxel

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Topotecan

Intervention Type: DRUG

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.

Interventions

Cabazitaxel

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

XRP6258

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

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

Investigational Site Number 152001

Santiago, , Chile

Investigational Site Number 152005

Santiago, , Chile

Investigational Site Number 250005

Brest, , France

Investigational Site Number 250004

Caen, , France

Investigational Site Number 250006

La Tronche, , France

Investigational Site Number 250002

Lille, , France

Investigational Site Number 250003

Saint-Herblain, , France

Investigational Site Number 250007

Villejuif, , France

Investigational Site Number 276003

Großhansdorf, , Germany

Investigational Site Number 276006

Löwenstein, , Germany

Investigational Site Number 300005

Athens, , Greece

Investigational Site Number 300003

Athens, , Greece

Investigational Site Number 300001

Heraklion, , Greece

Investigational Site Number 300002

Thessaloniki, , Greece

Investigational Site Number 300004

Thessaloniki, , Greece

Investigational Site Number 348001

Budapest, , Hungary

Investigational Site Number 348004

Budapest, , Hungary

Investigational Site Number 348002

Budapest, , Hungary

Investigational Site Number 348003

Törökbálint, , Hungary

Investigational Site Number 380001

Genova, , Italy

Investigational Site Number 380002

Livorno, , Italy

Investigational Site Number 380005

Novara, , Italy

Investigational Site Number 380004

Parma, , Italy

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 616003

Lublin, , Poland

Investigational Site Number 616002

Poznan, , Poland

Investigational Site Number 616001

Warsaw, , Poland

Investigational Site Number 642003

Cluj-Napoca, , Romania

Investigational Site Number 642005

Cluj-Napoca, , Romania

Investigational Site Number 642001

Craiova, , Romania

Investigational Site Number 642002

Timișoara, , Romania

Investigational Site Number 643001

Moscow, , Russia

Investigational Site Number 643005

Saint Petersburg, , Russia

Investigational Site Number 643006

Tula, , Russia

Investigational Site Number 643003

Yaroslavl, , Russia

Investigational Site Number 410001

Seoul, , South Korea

Investigational Site Number 410003

Seoul, , South Korea

Investigational Site Number 410002

Seoul, , South Korea

Investigational Site Number 724002

Badalona, , Spain

Investigational Site Number 724004

Barcelona, , Spain

Investigational Site Number 724005

Málaga, , Spain

Investigational Site Number 724001

Valencia, , Spain

Investigational Site Number 804002

Dnipropetrovsk, , Ukraine

Investigational Site Number 804004

Donetsk, , Ukraine

Investigational Site Number 804001

Lviv, , Ukraine

Countries

United States; Brazil; Canada; Chile; France; Germany; Greece; Hungary; Italy; Norway; Poland; Romania; Russia; South Korea; Spain; Ukraine

References

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.

Reference Type: DERIVED

PMID: 30537991 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26200278 (View on PubMed)

Other Identifiers

2011-003415-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1123-3503

Identifier Type: OTHER

Identifier Source: secondary_id

ARD12166

Identifier Type: -

Identifier Source: org_study_id