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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00675012
First received: May 5, 2008
Last updated: May 29, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: May 5, 2008
Last Updated: May 29, 2014
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014