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NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675012
First Posted: May 8, 2008
Last Update Posted: May 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MolMed S.p.A.
  Purpose
The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments

Condition Intervention Phase
Colon Cancer Drug: NGR-hTNF Drug: Oxaliplatin Drug: capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the feasibility and safety of NGRhTNF administered at low (0.8 mcg/sqm) and high (45 mcg/sqm) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer. [ Time Frame: during the study ]

Secondary Outcome Measures:
  • Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival [ Time Frame: during the study ]
  • Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII [ Time Frame: before during and following the treatment ]

Enrollment: 24
Study Start Date: December 2007
Study Completion Date: May 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv 0.8 or 45 mcg/sqm q3W
Drug: Oxaliplatin
iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
Drug: capecitabine
orally 825 mg/sqm 2qDx14

Detailed Description:
Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years with metastatic colorectal cancer (CRC) treated with no more than three standard systemic regimens (including biologic agents) for metastatic disease
  • Life expectancy more than 3 months
  • ECOG Performance status 0-1
  • 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
    • Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
  • 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 must 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
  • 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
  • Symptomatic peripheral neuropathy ≥ grade 1 according the NCI CTCAE v.3.0.
  • Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
  • Known hypersensitivity/allergic reaction or contraindications to platinum compounds or fluoropyrimidines
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675012


Locations
Italy
Azienda Ospedaliera Universitaria San Martino
Genoa, Italy, 16132
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Principal Investigator: Alberto Sobrero, MD Azienda Ospedaliera Universitaria San Martino Genoa, Italy
  More Information

Publications:
Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00675012     History of Changes
Other Study ID Numbers: NGR005
2007-003668-24 ( EudraCT Number )
First Submitted: May 5, 2008
First Posted: May 8, 2008
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by MolMed S.p.A.:
NGR-hTNF
Capecitabine
Oxaliplatin
Colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents