Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma
Condition: Small Cell Lung Cancer
MeSH terms: Small Cell Lung Carcinoma; Lung Neoplasms
Intervention: NGR-hTNF; Doxorubicin
Intervention description: iv q3W 0.8 mcg/sqm NGR-hTNF; iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion
Intervention MeSH terms: Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NGR-hTNF; SCLC

Summary:

      The main objective of the trial is to document the progression free survival (PFS) in
      advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at
      least one therapeutic regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic
             regimen (including doxorubicin). However, in case of patient already pretreated with
             doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and
             the current treatment has to be stopped when a maximum cumulative dose of doxorubicin
             550 mg/m^2 is reached.

          -  Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent
             disease do not require a confirmatory biopsy to be eligible)

          -  Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by
             conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria

          -  ECOG Performance status 0 - 2

          -  Adequate baseline bone marrow, hepatic and renal function, defined as follows:

               -  Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L

               -  Bilirubin < 1.5 x ULN

               -  AST and/or ALT < 2.5 x ULN in absence of liver metastasis

               -  AST and/or ALT < 5 x ULN in presence of liver metastasis

               -  Serum creatinine < 1.5 x ULN

          -  Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension

          -  Patients may have had prior therapy providing the following conditions are met:

             - Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period
             of 28 days before start treatment

             - Surgery: wash-out period of 14 days before start treatment

          -  Patients must give written informed consent to participate in the study

        Exclusion Criteria:

          -  Concurrent anticancer therapy

          -  Patients may not receive any other investigational agents while on study

          -  Patients with myocardial infarction within the last six (6) months, unstable angina,
             New York Heart Association (NYHA) grade II or greater congestive heart failure, or
             serious cardiac arrhythmia requiring medication

          -  Uncontrolled hypertension

          -  Prolonged QTc interval (congenital or acquired)

          -  Patient with significant peripheral vascular disease

          -  Previous signs of cardiotoxicity doxorubicin related

          -  Clinical signs of CNS involvement

          -  Patients with active or uncontrolled systemic disease/infections or with serious
             illness or medical conditions, which is incompatible with the protocol

          -  Known hypersensitivity/allergic reaction or contraindications to human albumin
             preparations or to any of the excipients

          -  Known hypersensitivity/allergic reaction or contraindications to anthracyclines

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering compliance with the study protocol

          -  Pregnancy or lactation. Patients - both males and females - with reproductive
             potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
             practice effective contraceptive measures throughout the study. Women of childbearing
             potential must provide a negative pregnancy test (serum or urine) within 14 days prior
             to registration.