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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00483080
First received: June 5, 2007
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer (CRC)
Drug: NGR-hTNF
Phase 2

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

Resource links provided by NLM:


Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Antitumour activity defined as Progression Free Survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor Growth Control Rate (TGCR) according to RECIST criteria [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Circulating tumor cells (CTCs) [ Time Frame: before and following the treatment ] [ Designated as safety issue: No ]
  • Experimental imaging study (DCE-MRI) [ Time Frame: before and following the first cycle ] [ Designated as safety issue: No ]
  • Pharmacokinetic in patients treated with weekly schedule [ Time Frame: before, during and following the treatment ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: during and following the treatment ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: December 2006
Study Completion Date: April 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv q3W or q1W NGR-hTNF 0.8 μg/m²

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483080

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Azienda Ospedaliera Universitaria "San Martino"
Genoa, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Principal Investigator: Federico Caligaris Cappio, MD Fondazione San Raffaele del Monte Tabor
  More Information

Publications:
Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00483080     History of Changes
Other Study ID Numbers: NGR006, 2006-005451-15
Study First Received: June 5, 2007
Last Updated: May 29, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by MolMed S.p.A.:
NGR-hTNF
CRC

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 16, 2014