Maintenance treatment with Lanreotide in Patients with small cell lung cancer expressing SST receptors, responsive to a first line standard chemotherapy/radiotherapy

• Conditions: Small cell lung cancer; MedDRA version: 14.1Level: LLTClassification code 10029882Term: Oat cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005730-20-IT
• Lead Sponsor: A.O. UNIVERSITARIA INTEGRATA DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1.Age > 18 and < 75 2.Histological or cytological proven diagnosis of small-cell lung cancer (SCLC) LD and ED 3.Complete response or partial response after a first line standard chemotherapy/radiotherapy completed no more than 45 days before enrollment 4.SST receptors expression (as detected by Octreoscan uptake at diagnosis) 5.Performance Status (ECOG) 0-2 6.Life expectancy greater than 3 months 7.Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 14 days prior to the start of the study treatment (leucocyte count >3.000/µl, neutrophils >1.500/µl, platelet count >100.000/µl, total bilirubin <1.5 times the upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, serum creatinine <1.25xULN (or >1.25xULN and <1.5xULN with creatinine clearance >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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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