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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

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


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 the least one
therapeutic regimen, that will be conducted using Simon's two-stage design method.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumour activity defined as progression free survival (PFS)

Outcome Time Frame:

during the trial

Safety Issue:

No

Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.

Authority:

Italy: Ethics Committee

Study ID:

NGR007

NCT ID:

NCT00483509

Start Date:

December 2006

Completion Date:

June 2013

Related Keywords:

  • Small Cell Lung Cancer
  • NGR-hTNF
  • SCLC
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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