Study of Nab-paclitaxel in Sensitive and Refractory Relapsed SCLC
NCT ID: NCT03219762
Last Updated: 2017-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
65 participants
INTERVENTIONAL
2017-02-07
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Nab-paclitaxel
Nab-paclitaxel (30-min infusion) 100 mg/sqm weekly on days 1, 8, 15 q 28 days.
Nabpaclitaxel
Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study
Interventions
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Nabpaclitaxel
Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female and ≥ 18 years of age
* Life expectancy ≥ 12 weeks
* Have progressed after or during platinum-based standard chemotherapy regimen (cisplatin or carboplatin and etoposide) for first-line treatment of SCLC, either limited stage (LD) or extensive stage (ED) disease and have not received any other treatment (except for immunotherapy as maintenance treatment), including re-treatment with front-line regimen
* Have measurable disease per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1); clear radiological evidence of disease progression after first-line therapy has to be documented; no previous radiotherapy on the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Patients with treated brain metastases with stable lesions for at least 2 weeks and off steroids or on a stable dose of steroids. Radiotherapy must have been completed a minimum of 14 days prior to registration, and patients must have recovered from AEs related to radiotherapy to \< grade 1 (except alopecia)
* For Females: must be postmenopausal (defined as occurring 12 months after last menstrual period) before the screening visit, or are surgically sterile. If they are of childbearing potential, a negative serum pregnancy test prior to study entry has to be documented; furthermore, they agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
* For Males: even if surgically sterilized (i.e. post-vasectomy status) agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
* Screening clinical laboratory values as specified below:
* Absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3 and haemoglobin ≥ 9 g/dL
* Total bilirubin \< 1.5 the institutional upper limit of normal (ULN)
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 the institutional ULN (\< 5 if liver function test elevations are due to liver metastases)
* Creatinine \< 1.5 institutional ULN or estimated creatinine clearance using the Cockcroft-Gault formula ≥ 30 mL/minute for patients with creatinine levels above institutional limits
Exclusion Criteria
* Prior radiotherapy is allowed provided that it has been completed more than 2 weeks before starting Nab-paclitaxel
* Ability to comply with protocol requirements
* The patient or the patient's legal representative has to be able to provide written informed consent. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
* Any prior not platinum-based chemotherapy treatment for SCLC or large-cell neuroendocrine carcinoma (LCNEC) or poorly differentiated (G3) neuroendocrine cancer of the lung (according WHO classification 2015) (immunotherapy is allowed as maintenance treatment)
* Prior treatment with Nab-paclitaxel, paclitaxel or any other taxane agent
* Known hypersensitivity to Cremophor EL®, paclitaxel, or its components
* Any comorbid condition or unresolved toxicity that would preclude administration of weekly Nab-paclitaxel
* Prior history of Grade ≥ 2 neurotoxicity that is not resolved to ≤ Grade 1
* Patients with symptomatic and/or progressive brain metastases or with carcinomatous meningitis
* Diagnosed with or treated for another malignancy within 3 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type may be enrolled in the study if they have undergone complete resection and no evidence of active disease is present
* History of myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac arrhythmias of Grade \> 2, thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (egg, pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving the first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. Patients with a pacemaker may be enrolled in the study upon discussion with the project clinician
* Infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug
* For female subjects: positive serum pregnancy test, pregnancy or breast feeding
* Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrolment and not fully recovered to baseline or to a stable clinical status. Insertion of a vascular device is allowed
* Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel
18 Years
ALL
No
Sponsors
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Temas srl
UNKNOWN
Clirest s.r.l.
OTHER
Mipharm S.p.A.
UNKNOWN
Istituto Toscano Tumori
OTHER
Gruppo Oncologico Italiano di Ricerca Clinica
OTHER
Responsible Party
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Locations
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UO di Oncologia Ematologia, Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, Italy
Sezione Pneumo-Oncologica - Medicina Interna I; IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Foggia, Italy
Oncologia Medica, IRST. Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori, IRCCS di Meldola
Meldola, Forlì-Cesena, Italy
Oncologia Medica - Ospedale Versilia
Lido di Camaiore, Lucca, Italy
SC di Oncologia Medica, A.O. San Gerardo di Monza
Monza, MB, Italy
UO Medicina Oncologica Ospedale di Carpi (MO)
Carpi, Modena, Italy
UOC di Oncologia Medica - Ospedale di Saronno
Saronno, Varese, Italy
UOC Oncologia Medica, Azienda ULSS21 di Legnago
Legnago, Verona, Italy
Oncologia Medica, Ospedale Sacro Cuore - Don Calabria - Negrar (VR)
Negrar, Verona, Italy
SC Oncologia - ASO "SS Antonio e Biagio e Cesare Arrigo,Alessandria
Alessandria, , Italy
Cliniche Humanitas Gavazzeni
Bergamo, , Italy
Oncologia Medica, Ospedale Papa Giovanni XXIII
Bergamo, , Italy
UO di Oncologia Medica, Azienda Ospedaliero-Universitaria S. Orsola Malpighi di Bologna,
Bologna, , Italy
Divisione di Oncologia Medica - Ospedale di Bolzano,
Bolzano, , Italy
UOC Oncologia Medica PO A.Perino ASL di Brindisi
Brindisi, , Italy
SC di Oncologia, Istituti Ospitalieri di Cremona
Cremona, , Italy
Dipartimento di Oncologia Medica A.O. Santa Croce e Carle Ospedale Carle
Cuneo, , Italy
Azienda Ospedaliera Careggi, UO di Oncologia Medica
Florence, , Italy
UOC Oncologia, Azienda USL di Imola, Ospedale Santa Maria della Scaletta
Imola, , Italy
Dipartimento Oncologico, Azienda USL 2 di Lucca, Ospedale San Luca
Lucca, , Italy
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
Modena, , Italy
S. C. di Oncologia Medica AORN "Antonio Cardarelli"
Napoli, , Italy
UOC di Oncologia Medica di Parma, Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Dipartimento di Oncologia e Ematologia, UO di Oncologia Medica Azienda USL di Piacenza
Piacenza, , Italy
Dipartimento di Oncologia Ematologia. UO di Oncologia Medica, AUSL della Romagna, Ospedale Santa Maria delle Croci di Ravenna
Ravenna, , Italy
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
Torino, , Italy
Countries
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Central Contacts
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References
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Gelsomino F, Tiseo M, Barbieri F, Riccardi F, Cavanna L, Frassoldati A, Delmonte A, Longo L, Dazzi C, Cinieri S, Colantonio I, Sperandi F, Lamberti G, Brocchi S, Tofani L, Boni L, Ardizzoni A. Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL). Br J Cancer. 2020 Jul;123(1):26-32. doi: 10.1038/s41416-020-0845-3. Epub 2020 Apr 29.
Other Identifiers
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GOIRC-02-2016
Identifier Type: -
Identifier Source: org_study_id
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