NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
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
- Absence of any conditions in which hypervolaemia and its consequences (e.g. increased
stroke volume, elevated blood pressure) or haemodilution could represent a risk for
the patient (reference appendix "Technical data sheet human albumin")
- 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.