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

NCT01500720 | Completed Phase 2 Results

• 3 other identifiers: ARD121662011-003415-31U1111-1123-3503
• Study Type: interventional
• Target: 179
• Locations: 16 countries
• Sites: 58

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)

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)

Secondary Outcomes (3)

• Overall Survival

  From randomization to date of death (maximum 15 months)

• Progression Free Rate at Week 12

  Week 12

• Overall Objective Tumor Response Rate

  Randomization to disease progression/occurrence (maximum 7.6 months)

Study Arms (2)

Cabazitaxel

EXPERIMENTAL

Drug: Cabazitaxel

Topotecan

ACTIVE COMPARATOR

Drug: Topotecan

Interventions

Cabazitaxel 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.

Also known as: XRP6258

Cabazitaxel

Topotecan 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.

Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Sanofi: lead

Study Sites (58)

Investigational Site Number 840007

Muscle Shoals, Alabama, 35661, United States

Location

Investigational Site Number 840005

Omaha, Nebraska, 68114, United States

Location

Investigational Site Number 840006

Lebanon, New Hampshire, 03756, United States

Location

Investigational Site Number 840003

Middletown, Ohio, 45042, United States

Location

Investigational Site Number 840001

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 076001

Porto Alegre, 90610-000, Brazil

Location

Investigational Site Number 124003

Montreal, H3T 1E2, Canada

Location

Investigational Site Number 124002

Oshawa, L1G 2B9, Canada

Location

Investigational Site Number 124004

Rimouski, G5L 5T1, Canada

Location

Investigational Site Number 124001

Toronto, M5G 2M9, Canada

Location

Investigational Site Number 152001

Santiago, 8380456, Chile

Location

Investigational Site Number 152005

Santiago, Chile

Location

Investigational Site Number 250005

Brest, 29609, France

Location

Investigational Site Number 250004

Caen, 14033, France

Location

Investigational Site Number 250006

La Tronche, 38700, France

Location

Investigational Site Number 250002

Lille, 59800, France

Location

Investigational Site Number 250003

Saint-Herblain, 44805, France

Location

Investigational Site Number 250007

Villejuif, 94805, France

Location

Investigational Site Number 276003

Großhansdorf, 22927, Germany

Location

Investigational Site Number 276006

Löwenstein, 74245, Germany

Location

Investigational Site Number 300005

Athens, 11522, Greece

Location

Investigational Site Number 300003

Athens, 11527, Greece

Location

Investigational Site Number 300001

Heraklion, 71110, Greece

Location

Investigational Site Number 300002

Thessaloniki, 54629, Greece

Location

Investigational Site Number 300004

Thessaloniki, 57010, Greece

Location

Investigational Site Number 348001

Budapest, 1121, Hungary

Location

Investigational Site Number 348004

Budapest, 1121, Hungary

Location

Investigational Site Number 348002

Budapest, 1125, Hungary

Location

Investigational Site Number 348003

Törökbálint, 2045, Hungary

Location

Investigational Site Number 380001

Genova, 16132, Italy

Location

Investigational Site Number 380002

Livorno, 57123, Italy

Location

Investigational Site Number 380005

Novara, 28100, Italy

Location

Investigational Site Number 380004

Parma, 43100, Italy

Location

Investigational Site Number 578001

Oslo, 0440, Norway

Location

Investigational Site Number 578003

Stavanger, 4011, Norway

Location

Investigational Site Number 578002

Trondheim, 7006, Norway

Location

Investigational Site Number 616004

Gdansk, 80-952, Poland

Location

Investigational Site Number 616003

Lublin, 20-954, Poland

Location

Investigational Site Number 616002

Poznan, 60-569, Poland

Location

Investigational Site Number 616001

Warsaw, 02-781, Poland

Location

Investigational Site Number 642003

Cluj-Napoca, 400015, Romania

Location

Investigational Site Number 642005

Cluj-Napoca, 400015, Romania

Location

Investigational Site Number 642001

Craiova, 200385, Romania

Location

Investigational Site Number 642002

Timișoara, Romania

Location

Investigational Site Number 643001

Moscow, 115478, Russia

Location

Investigational Site Number 643005

Saint Petersburg, 197758, Russia

Location

Investigational Site Number 643006

Tula, 300053, Russia

Location

Investigational Site Number 643003

Yaroslavl, 150054, Russia

Location

Investigational Site Number 410001

Seoul, 120-752, South Korea

Location

Investigational Site Number 410003

Seoul, 135-710, South Korea

Location

Investigational Site Number 410002

Seoul, 138-736, South Korea

Location

Investigational Site Number 724002

Badalona, 08916, Spain

Location

Investigational Site Number 724004

Barcelona, 08035, Spain

Location

Investigational Site Number 724005

Málaga, 29010, Spain

Location

Investigational Site Number 724001

Valencia, 46026, Spain

Location

Investigational Site Number 804002

Dnipropetrovsk, 49102, Ukraine

Location

Investigational Site Number 804004

Donetsk, 83092, Ukraine

Location

Investigational Site Number 804001

Lviv, 70031, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 30537991 DERIVED

• 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.

  PMID: 26200278 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

cabazitaxel; XRP6258; Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: March 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 13, 2015
• Results First Posted: April 13, 2015

Record last verified: 2015-03

Locations

RU (4); FR (6); ES (4); IT (4); US (5); NO (3); PL (4); UA (3); GR (5); HU (4); DE (2); RO (4); BR (1); KR (3); CL (2); CA (4)