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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

Phase 2
18 Years
Open (Enrolling)
Colon Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

during the study

Safety Issue:


Principal Investigator

Alberto Sobrero, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Ospedaliera Universitaria San Martino Genoa, Italy


Italy: Ethics Committee

Study ID:




Start Date:

December 2007

Completion Date:

June 2013

Related Keywords:

  • Colon Cancer
  • NGR-hTNF
  • Capecitabine
  • Oxaliplatin
  • Colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms