Small cell lung cancer MedDRA version: 14.1 Level: LLT Classification code 10029882 Term: Oat cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IPSTYL*SC SIR 120MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LANREOTIDE ACETATE
CAS Number: 127984-74-1
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age > 18 and 3.000/µl, neutrophils >1.500/µl, platelet count >100.000/µl, total bilirubin 1.25xULN and 60ml/min) 8.Negative pregnancy test (only for fertile women who must use effective contraception) 9.Patients must be accessible for treatment and follow up. 10.Patients must be able to understand and sign written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Stable disease (SD) or progression (PD) after a first-line standard treatment (CT / RT) 2.Time > 45 days after the first line standard therapy 3.Clinically significant cardiovascular disease e.g. cerebrovascular accidents (=6 months), myocardial infarction (=6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication 4.Intercurrent and not controlled acute infectious disease 5.Psychological or social conditions which might affect study compliance 6.Severe Parkinson disease 7.Unstable neurologic function 8.Known history of atrophic gastritis 9.Known history of cholelithiasis 10.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized cancers (eg. Non melanoma skin cancer, cervical ) effectively treated 11. Patients with known allergy to any of the components of the study medication 12.Pregnancy or lactation 13.Treatment with any investigational drug within 30 days prior to enrolment 14.Prior treatment with somatostatin analoques.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness, in terms of improved time to disease progression (or progression-free survival, PFS) at 1 year, of maintenance therapy with 120 mg Lanreotide (injection) vs control, in patients affected by SCLC (LD/ED),in patients with SCLC (LD / ED), Octreoscan positive, and who have obtained a response (partial or complete) after a I line standard therapy. PFS is defined as the time from study enrolment to first observation of local or metastatic disease progression or death (or both) for any reason.;Secondary Objective: - To establish the safety of treatment with Lanreotide after standard Chemo/radiotherapy in patients with SCLC. - To establish the Overall Survival (OS) at 2 years, defined as as the% of patients alive at 2 years of diagnosis of SCLC.;Primary end point(s): PFS progression-free survival at 1 year of maintenance therapy;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall Survival (OS) at 2 years, - Criteria CTCs (as defined on NCI) to evaluate tossicity;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Italy
Contacts
Public Contactcro
INFORMA S.r.l.
Outcome results
None listed