Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
maanantai 30. maaliskuuta 2015 päivittänyt: Sanofi
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)
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
179
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Porto Alegre, Brasilia, 90610-000
- Investigational Site Number 076001
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Santiago, Chile, 8380456
- Investigational Site Number 152001
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Santiago, Chile
- Investigational Site Number 152005
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Badalona, Espanja, 08916
- Investigational Site Number 724002
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Barcelona, Espanja, 08035
- Investigational Site Number 724004
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Málaga, Espanja, 29010
- Investigational Site Number 724005
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Valencia, Espanja, 46026
- Investigational Site Number 724001
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Genova, Italia, 16132
- Investigational Site Number 380001
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Livorno, Italia, 57123
- Investigational Site Number 380002
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Novara, Italia, 28100
- Investigational Site Number 380005
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Parma, Italia, 43100
- Investigational Site Number 380004
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Montreal, Kanada, H3T 1E2
- Investigational Site Number 124003
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Oshawa, Kanada, L1G 2B9
- Investigational Site Number 124002
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Rimouski, Kanada, G5L 5T1
- Investigational Site Number 124004
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Toronto, Kanada, M5G 2M9
- Investigational Site Number 124001
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Seoul, Korean tasavalta, 120-752
- Investigational Site Number 410001
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Seoul, Korean tasavalta, 135-710
- Investigational Site Number 410003
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Seoul, Korean tasavalta, 138-736
- Investigational Site Number 410002
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Athens, Kreikka, 11522
- Investigational Site Number 300005
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Athens, Kreikka, 11527
- Investigational Site Number 300003
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Heraklion, Kreikka, 71110
- Investigational Site Number 300001
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Thessaloniki, Kreikka, 54629
- Investigational Site Number 300002
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Thessaloniki, Kreikka, 57010
- Investigational Site Number 300004
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Oslo, Norja, 0440
- Investigational Site Number 578001
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Stavanger, Norja, 4011
- Investigational Site Number 578003
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Trondheim, Norja, 7006
- Investigational Site Number 578002
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Gdansk, Puola, 80-952
- Investigational Site Number 616004
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Lublin, Puola, 20-954
- Investigational Site Number 616003
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Poznan, Puola, 60-569
- Investigational Site Number 616002
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Warszawa, Puola, 02-781
- Investigational Site Number 616001
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Brest, Ranska, 29609
- Investigational Site Number 250005
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Caen Cedex, Ranska, 14033
- Investigational Site Number 250004
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La Tronche, Ranska, 38700
- Investigational Site Number 250006
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Lille, Ranska, 59800
- Investigational Site Number 250002
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Saint-Herblain Cedex, Ranska, 44805
- Investigational Site Number 250003
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Villejuif Cedex, Ranska, 94805
- Investigational Site Number 250007
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Cluj Napoca, Romania, 400015
- Investigational Site Number 642003
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Cluj-Napoca, Romania, 400015
- Investigational Site Number 642005
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Craiova, Romania, 200385
- Investigational Site Number 642001
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Timisoara, Romania
- Investigational Site Number 642002
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Großhansdorf, Saksa, 22927
- Investigational Site Number 276003
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Löwenstein, Saksa, 74245
- Investigational Site Number 276006
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Dnipropetrovsk, Ukraina, 49102
- Investigational Site Number 804002
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Donetsk, Ukraina, 83092
- Investigational Site Number 804004
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Lviv, Ukraina, 70031
- Investigational Site Number 804001
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Budapest, Unkari, 1121
- Investigational Site Number 348001
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Budapest, Unkari, 1121
- Investigational Site Number 348004
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Budapest, Unkari, 1125
- Investigational Site Number 348002
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Törökbálint, Unkari, 2045
- Investigational Site Number 348003
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Moscow, Venäjän federaatio, 115478
- Investigational Site Number 643001
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St-Petersburg, Venäjän federaatio, 197758
- Investigational Site Number 643005
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Tula, Venäjän federaatio, 300053
- Investigational Site Number 643006
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Yaroslavl, Venäjän federaatio, 150054
- Investigational Site Number 643003
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Alabama
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Muscle Shoals, Alabama, Yhdysvallat, 35661
- Investigational Site Number 840007
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68114
- Investigational Site Number 840005
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New Hampshire
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Lebanon, New Hampshire, Yhdysvallat, 03756
- Investigational Site Number 840006
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Ohio
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Middletown, Ohio, Yhdysvallat, 45042
- Investigational Site Number 840003
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Pennsylvania
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Philadelphia, Pennsylvania, Yhdysvallat, 19104
- Investigational Site Number 840001
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Kabatsitakseli
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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.
Muut nimet:
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Active Comparator: Topotekaani
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Progression Free Survival (PFS)
Aikaikkuna: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
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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.
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Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Overall Survival
Aikaikkuna: From randomization to date of death (maximum 15 months)
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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.
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From randomization to date of death (maximum 15 months)
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Progression Free Rate at Week 12
Aikaikkuna: Week 12
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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.
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Week 12
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Overall Objective Tumor Response Rate
Aikaikkuna: Randomization to disease progression/occurrence (maximum 7.6 months)
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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.
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Randomization to disease progression/occurrence (maximum 7.6 months)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Torstai 1. maaliskuuta 2012
Ensisijainen valmistuminen (Todellinen)
Tiistai 1. huhtikuuta 2014
Opintojen valmistuminen (Todellinen)
Tiistai 1. huhtikuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 22. joulukuuta 2011
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 27. joulukuuta 2011
Ensimmäinen Lähetetty (Arvio)
Keskiviikko 28. joulukuuta 2011
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Maanantai 13. huhtikuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 30. maaliskuuta 2015
Viimeksi vahvistettu
Sunnuntai 1. maaliskuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Neoplasmat
- Keuhkosairaudet
- Neoplasmat sivustoittain
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Keuhkojen kasvaimet
- Pienisoluinen keuhkosyöpä
- Farmakologisen vaikutuksen molekyylimekanismit
- Entsyymin estäjät
- Antineoplastiset aineet
- Topoisomeraasin estäjät
- Topoisomeraasi I:n estäjät
- Topotekaani
Muut tutkimustunnusnumerot
- ARD12166
- 2011-003415-31 (EudraCT-numero)
- U1111-1123-3503 (Muu tunniste: UTN)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .