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Small Cell Lung CancerPhase 2NCT01500720

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

A Phase 2 study testing Cabazitaxel and Topotecan in people with Small Cell Lung Cancer, run by Sanofi at 58 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Cabazitaxel and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
58 sitesin 16 countries
Study dates
Mar 2012to Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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.

Trial locations and contacts

58 sites in 16 countries.

58 sites in 16 countries

France6 sites

  • Investigational Site Number 250005

    Brest, 29609

  • Investigational Site Number 250004

    Caen, 14033

  • Investigational Site Number 250006

    La Tronche, 38700

  • Investigational Site Number 250002

    Lille, 59800

  • Investigational Site Number 250003

    Saint-Herblain, 44805

  • Investigational Site Number 250007

    Villejuif, 94805

Other trials in France

United States5 sites

  • Investigational Site Number 840006

    Lebanon, New Hampshire, 03756

  • Investigational Site Number 840003

    Middletown, Ohio, 45042

  • Investigational Site Number 840007

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840005

    Omaha, Nebraska, 68114

  • Investigational Site Number 840001

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Greece5 sites

  • Investigational Site Number 300005

    Athens, 11522

  • Investigational Site Number 300003

    Athens, 11527

  • Investigational Site Number 300001

    Heraklion, 71110

  • Investigational Site Number 300002

    Thessaloniki, 54629

  • Investigational Site Number 300004

    Thessaloniki, 57010

Other trials in Greece

Canada4 sites

  • Investigational Site Number 124003

    Montreal, H3T 1E2

  • Investigational Site Number 124002

    Oshawa, L1G 2B9

  • Investigational Site Number 124004

    Rimouski, G5L 5T1

  • Investigational Site Number 124001

    Toronto, M5G 2M9

Other trials in Canada

Hungary4 sites

  • Investigational Site Number 348001

    Budapest, 1121

  • Investigational Site Number 348004

    Budapest, 1121

  • Investigational Site Number 348002

    Budapest, 1125

  • Investigational Site Number 348003

    Törökbálint, 2045

Other trials in Hungary

Italy4 sites

  • Investigational Site Number 380001

    Genova, 16132

  • Investigational Site Number 380002

    Livorno, 57123

  • Investigational Site Number 380005

    Novara, 28100

  • Investigational Site Number 380004

    Parma, 43100

Other trials in Italy

Poland4 sites

  • Investigational Site Number 616004

    Gdansk, 80-952

  • Investigational Site Number 616003

    Lublin, 20-954

  • Investigational Site Number 616002

    Poznan, 60-569

  • Investigational Site Number 616001

    Warsaw, 02-781

Other trials in Poland

Romania4 sites

  • Investigational Site Number 642003

    Cluj-Napoca, 400015

  • Investigational Site Number 642005

    Cluj-Napoca, 400015

  • Investigational Site Number 642001

    Craiova, 200385

  • Investigational Site Number 642002

    Timișoara

Other trials in Romania

Russia4 sites

  • Investigational Site Number 643001

    Moscow, 115478

  • Investigational Site Number 643005

    Saint Petersburg, 197758

  • Investigational Site Number 643006

    Tula, 300053

  • Investigational Site Number 643003

    Yaroslavl, 150054

Other trials in Russia

Spain4 sites

  • Investigational Site Number 724002

    Badalona, 08916

  • Investigational Site Number 724004

    Barcelona, 08035

  • Investigational Site Number 724005

    Málaga, 29010

  • Investigational Site Number 724001

    Valencia, 46026

Other trials in Spain

Norway3 sites

  • Investigational Site Number 578001

    Oslo, 0440

  • Investigational Site Number 578003

    Stavanger, 4011

  • Investigational Site Number 578002

    Trondheim, 7006

Other trials in Norway

South Korea3 sites

  • Investigational Site Number 410001

    Seoul, 120-752

  • Investigational Site Number 410003

    Seoul, 135-710

  • Investigational Site Number 410002

    Seoul, 138-736

Other trials in South Korea

Ukraine3 sites

  • Investigational Site Number 804002

    Dnipropetrovsk, 49102

  • Investigational Site Number 804004

    Donetsk, 83092

  • Investigational Site Number 804001

    Lviv, 70031

Other trials in Ukraine

Chile2 sites

  • Investigational Site Number 152001

    Santiago, 8380456

  • Investigational Site Number 152005

    Santiago

Other trials in Chile

Germany2 sites

  • Investigational Site Number 276003

    Großhansdorf, 22927

  • Investigational Site Number 276006

    Löwenstein, 74245

Other trials in Germany

Brazil1 site

  • Investigational Site Number 076001

    Porto Alegre, 90610-000

Other trials in Brazil

About this study

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

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)
Read the 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.

Being tested
Cabazitaxel, Topotecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called XRP6258

    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.

  • TopotecanDrug

    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.

Study groups in NCT01500720
Study groupRoleWhat they receive
CabazitaxelExperimentalNot described
Receives: Drug: Cabazitaxel
TopotecanActive comparatorNot described
Receives: Drug: Topotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Overall Survival

    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.

    Measured: From randomization to date of death (maximum 15 months)

  2. Progression Free Rate at 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.

    Measured: Week 12

  3. Overall Objective Tumor Response Rate

    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.

    Measured: Randomization to disease progression/occurrence (maximum 7.6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500720
Sponsor's protocol ID
ARD12166
Other IDs
2011-003415-31, U1111-1123-3503
Status last verified
Mar 2015
First submitted
22 Dec 2011
Last updated
13 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 30537991

  • 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.

    PubMed 26200278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel and Topotecan in people with Small Cell Lung Cancer, run by Sanofi at 58 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in France, United States, Greece, Canada, Hungary and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500720, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.

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