Clinical trial NCT00483509 (phase 2, status: completed)
Conditions: small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: ngr-htnf, doxorubicin
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
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.