sensitive and refractory relapsed small cells lung cancer (SCLC) MedDRA version: 21.1 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10037351 Term: Pulmonary carcinoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO
Product Name: nab-Paliclitaxel
Product Code: [ABRAXANE]
Pharmaceutical
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 = 1500/mm3, platelet count> = 100,000/mm3 and haemoglobin >= 9 g/dL o Total bilirubin = 30 mL/minute for patients with creatinine levels above institutional limits • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria • 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
Exclusion criteria
Exclusion criteria: • • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the therapeutic activity of Nab-Paclitaxel in subjects with sensitive and refractory small cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC) relapsed after cisplatin or carboplatin and etoposide first line chemotherapy.;Secondary Objective: To evaluate safety and efficacy of Nab-Paclitaxel in subjects with sensitive and refractory small cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma (LCNEC) relapsed after cisplatin or carboplatin and etoposide first line chemotherapy;Primary end point(s): The primary end-point is objective tumor response that will be evaluated according to standard RECIST 1.1 criteria and will be based on the Investigator’s assessment. Data will be reported as percentage of complete responses (CRs), partial responses (PRs), stable disease (SD) and progressive disease (PD). Exact binomial method will be used to estimate the response rate (CR+PR) and its 95% confidence interval. Patients with no tumor assessment after baseline will be classified as non-responders. ;Timepoint(s) of evaluation of this end point: In the present study, tumor will be re-evaluated after completion of every 2 cycles of treatment, i.e. approximately every 8 weeks ±1 week, and at least 4 weeks after the first observation of a complete or partial response. After discontinuation of protocol treatment, patients who have not progressed will still be re-evaluated every 8 weeks ±1 week, unless they have started a new anti-cancer therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Toxicity: the assessment of safety will be based mainly on the frequency of adverse events; toxicity will be measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 4.03. ; 2. Progression Free Survival (PFS) will be calculated from the patient registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free or alive. ; Overall Survival (OS) will be calculated from the registration to death from any cause, or the last date the patient was known to be alive.;Timepoint(s) of evaluation of this end point: End of study; from the patient registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free or alive. ; from the registration to death from any cause, or the last date the patient was known to be alive. | — |
Countries
Italy
Contacts
Public ContactUOC di ONCOLOGIA MEDICA AZ. OSPEDAL
GOIRC Gruppo Oncologico Italiano di Ricerca Clinica
Outcome results
None listed