Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)

Colorectal Cancer (CRC) Clinical Trial

Official title:

NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483080
• Other study ID #: NGR006
• Secondary ID: 2006-005451-15
• Status: Completed
• Phase: Phase 2
• Start date: December 2006
• Est. completion date: April 2013

Study information

• Verified date: January 2019
• Source: MolMed S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Description:

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using Simon's two-stage design method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2013
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients >18 years affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, but not more than three lines of therapy. Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy

• ECOG Performance status 0 - 1

• Patients in progression disease at study entry, CT documented

• 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 metastases

• AST and/or ALT < 5 x ULN in presence of liver metastases

• Serum creatinine < 1.5 x ULN

• Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or hemodilution could represent a risk for the patient (reference appendix "Technical data sheet human albumin")

• Normal cardiac function and absence of uncontrolled hypertension

• Patients must give written informed consent to participate in the study

Exclusion Criteria:

• More than three lines of chemotherapy (except biological agents)

• Concurrent anticancer therapy

• Patients may not receive any other investigational agents while on study

• 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 to human albumin preparations or to any of the excipients

• 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

Related Conditions & MeSH terms

• Colorectal Cancer (CRC)
• Colorectal Neoplasms

Intervention

Drug:
• NGR-hTNF
iv q3W or q1W NGR-hTNF 0.8 µg/m²

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria "San Martino"	Genoa
Italy	Fondazione San Raffaele del Monte Tabor	Milan
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
MolMed S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Santoro A, Rimassa L, Sobrero AF, Citterio G, Sclafani F, Carnaghi C, Pessino A, Caprioni F, Andretta V, Tronconi MC, Finocchiaro G, Rossoni G, Zanoni A, Miggiano C, Rizzardi GP, Traversari C, Caligaris-Cappio F, Lambiase A, Bordignon C. Phase II study of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)	during the study
Secondary	Tumor Growth Control Rate (TGCR)	TGCR evaluated according to Response evaluation criteria in solid tumors (RECIST)	during the study
Secondary	Overall survival (OS)	Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive	during the study
Secondary	Circulating tumor cells (CTCs)	To document modification of CTCs	before and following the treatment
Secondary	Experimental imaging study (DCE-MRI)	to document possible modifications on vessels permeability	before and following the first cycle
Secondary	to evaluate AUC(tau) of NGR-hTNF in patients treated with weekly schedule	to evaluate AUC(tau) of NGR-hTNF administered weekly	during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)
Secondary	?to evaluate Cmax of NGR-hTNF in patients treated with weekly schedule	to evaluate Cmax of NGR-hTNF administered weekly	during the first 6 weeks (time points: prior to infusion, 20 minutes, 60 minutes, 90 minutes, 120 minutes and 240 minutes after treatment start)
Secondary	Safety according to NCI-CTCAE criteria (version 3)	To evaluate safety profile related to NGR-hTNF	during and following the treatment