Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma (NGR007)

AGC Biologics

Status and phase

Completed

Phase 2

Conditions

Small Cell Lung Cancer

Treatments

Drug: Doxorubicin

Drug: NGR-hTNF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00483509

NGR007

2006-005700-14 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.