Study of Nab-paclitaxel in Sensitive and Refractory Relapsed SCLC

NCT03219762 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: GOIRC-02-2016
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 26

Brief Summary

Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The primary end-point is objective tumor response

  It will be evaluated according to standard RECIST 1.1 criteria and will be based on the Investigator's assessment.

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 weeks.

Secondary Outcomes (3)

• Frequency of Toxicity Events: frequency of moderate and severe toxicity events and drop-out rate due to therapy related toxicity

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 weeks.

• Progression Free Survival (PFS)

  From date of registration until the date of last documented progression or date of death from any cause, assessed up to 100 weeks

• Overall Survival (OS)

  From date of patient enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Nab-paclitaxel

EXPERIMENTAL

Nab-paclitaxel (30-min infusion) 100 mg/sqm weekly on days 1, 8, 15 q 28 days.

Drug: Nabpaclitaxel

Interventions

Nabpaclitaxel DRUG

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

Also known as: Abraxane

Nab-paclitaxel

Eligibility Criteria

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

You may qualify if:

• Pathologically (histology or cytology) confirmed diagnosis of small cell lung cancer (SCLC) or large-cell neuroendocrine carcinoma (LCNEC) or poorly differentiated (G3) neuroendocrine cancer of the lung (according to WHO classification 2015)
• 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

You may not qualify if:

• Recovered (i.e., ≤ Grade 1 toxicity) from effects of prior anticancer therapy, except alopecia
• 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

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead
• Temas srl: collaborator
• Clirest s.r.l.: collaborator
• Mipharm S.p.A.: collaborator
• Istituto Toscano Tumori: collaborator

Study Sites (26)

UO di Oncologia Ematologia, Azienda Ospedaliero Universitaria di Ferrara

Cona, Ferrara, 44124, Italy

RECRUITING

Sezione Pneumo-Oncologica - Medicina Interna I; IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, Foggia, 71013, Italy

NOT YET RECRUITING

Oncologia Medica, IRST. Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori, IRCCS di Meldola

Meldola, Forlì-Cesena, 47014, Italy

RECRUITING

Oncologia Medica - Ospedale Versilia

Lido di Camaiore, Lucca, 55043, Italy

NOT YET RECRUITING

SC di Oncologia Medica, A.O. San Gerardo di Monza

Monza, MB, 20900, Italy

NOT YET RECRUITING

UO Medicina Oncologica Ospedale di Carpi (MO)

Carpi, Modena, 41012, Italy

RECRUITING

UOC di Oncologia Medica - Ospedale di Saronno

Saronno, Varese, 21047, Italy

NOT YET RECRUITING

UOC Oncologia Medica, Azienda ULSS21 di Legnago

Legnago, Verona, 37045, Italy

NOT YET RECRUITING

Oncologia Medica, Ospedale Sacro Cuore - Don Calabria - Negrar (VR)

Negrar, Verona, 37024, Italy

NOT YET RECRUITING

SC Oncologia - ASO "SS Antonio e Biagio e Cesare Arrigo,Alessandria

Alessandria, 15121, Italy

NOT YET RECRUITING

Cliniche Humanitas Gavazzeni

Bergamo, 24125, Italy

NOT YET RECRUITING

Oncologia Medica, Ospedale Papa Giovanni XXIII

Bergamo, 24127, Italy

RECRUITING

UO di Oncologia Medica, Azienda Ospedaliero-Universitaria S. Orsola Malpighi di Bologna,

Bologna, 40138, Italy

RECRUITING

Divisione di Oncologia Medica - Ospedale di Bolzano,

Bolzano, 39100, Italy

RECRUITING

UOC Oncologia Medica PO A.Perino ASL di Brindisi

Brindisi, 72100, Italy

RECRUITING

SC di Oncologia, Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

NOT YET RECRUITING

Dipartimento di Oncologia Medica A.O. Santa Croce e Carle Ospedale Carle

Cuneo, 12100, Italy

RECRUITING

Azienda Ospedaliera Careggi, UO di Oncologia Medica

Florence, 50139, Italy

NOT YET RECRUITING

UOC Oncologia, Azienda USL di Imola, Ospedale Santa Maria della Scaletta

Imola, 40028, Italy

NOT YET RECRUITING

Dipartimento Oncologico, Azienda USL 2 di Lucca, Ospedale San Luca

Lucca, 55100, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia

Modena, 41100, Italy

RECRUITING

S. C. di Oncologia Medica AORN "Antonio Cardarelli"

Napoli, 80131, Italy

NOT YET RECRUITING

UOC di Oncologia Medica di Parma, Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

NOT YET RECRUITING

Dipartimento di Oncologia e Ematologia, UO di Oncologia Medica Azienda USL di Piacenza

Piacenza, 29121, Italy

RECRUITING

Dipartimento di Oncologia Ematologia. UO di Oncologia Medica, AUSL della Romagna, Ospedale Santa Maria delle Croci di Ravenna

Ravenna, 48121, Italy

RECRUITING

Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica

Torino, 10126, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 32346071 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Albumin-Bound Paclitaxel

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)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

GOIRC

CONTACT

00390512142204; nabsterstudy@gmail.com

Andrea Ardizzoni, PI

CONTACT

00390512142204; andrea.adizzoni@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, multicentre, study

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: July 18, 2017
• Study Start: February 7, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

IT (26)