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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:
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

May 5, 2008
May 29, 2014
December 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00675012 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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-RI [ Time Frame: before during and following the treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer
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

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colon Cancer
  • 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
Experimental: A
Interventions:
  • Drug: NGR-hTNF
  • Drug: Oxaliplatin
  • Drug: capecitabine
Mammoliti S, Andretta V, Bennicelli E, Caprioni F, Comandini D, Fornarini G, Guglielmi A, Pessino A, Sciallero S, Sobrero AF, Mazzola G, Lambiase A, Bordignon C. Two doses of NGR-hTNF in combination with capecitabine plus oxaliplatin in colorectal cancer patients failing standard therapies. Ann Oncol. 2011 Apr;22(4):973-8. Epub 2010 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2013
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00675012
NGR005, 2007-003668-24
No
MolMed S.p.A.
MolMed S.p.A.
Not Provided
Principal Investigator: Alberto Sobrero, MD Azienda Ospedaliera Universitaria San Martino Genoa, Italy
MolMed S.p.A.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP