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

NCT00483509 | Completed Phase 2 Results

• 2 other identifiers: NGR0072006-005700-14
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Small Cell Lung Cancer

Keywords

NGR-hTNF; SCLC

Outcome Measures

Primary Outcomes (1)

• Antitumour Activity Defined as Progression Free Survival (PFS)

  Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression

  From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks

Secondary Outcomes (4)

• Tumor Growth Control Rate (TGCR)

  Assessed every 6-12 weeks, up to 150 weeks

• Overall Survival (OS)

  Through study completion, an average of 3 years

• Experimental Imaging Study (DCE-MRI)

  during the study

• Number of Adverse Events, Reported by Severity and Relation to Treatment

  Through study completion, an average of 3 years

Study Arms (1)

A: NGR-hTNF + doxorubicin

EXPERIMENTAL

NGR-hTNF plus doxorubicin

Drug: NGR-hTNF; Drug: Doxorubicin

Interventions

NGR-hTNF DRUG

iv q3W 0.8 mcg/sqm NGR-hTNF

A: NGR-hTNF + doxorubicin

Doxorubicin DRUG

iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

A: NGR-hTNF + doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AGC Biologics S.p.A.: lead

Study Sites (5)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Turin, 10043, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genoa, 16132, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Fondazione San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Related Publications (1)

• Gregorc V, Cavina R, Novello S, Grossi F, Lazzari C, Capelletto E, Genova C, Salini G, Lambiase A, Santoro A. NGR-hTNF and Doxorubicin as Second-Line Treatment of Patients with Small Cell Lung Cancer. Oncologist. 2018 Oct;23(10):1133-e112. doi: 10.1634/theoncologist.2018-0292. Epub 2018 Aug 3.

  PMID: 30076277 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human; Doxorubicin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Clinical Operations
• Organization: Molmed S.p.A

clinical.operations@molmed.com

003902212771

Study Officials

• Antonio Lambiase, MD

  AGC Biologics S.p.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2007
• First Posted: June 7, 2007
• Study Start: February 14, 2007
• Primary Completion: September 22, 2010
• Study Completion: May 17, 2011
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Locations

IT (5)