?NGR005: Pilot study of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin-based regimen in patients wit metastatic colorectal cancer? - NGR005

• Conditions: Patients with metastatic colorectal cancer; MedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastatic

• Registration Number: EUCTR2007-003668-24-IT
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the feasibility and safety of NGR-hTNF administered at low (0.8 &#956;g/m2) and high (45 &#956;g/m2) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.;Secondary Objective: To document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival <br>To evaluate the pharmacokinetic profile of NGR-hTNF and to measure plasma levels of sTNF-RI and sTNF-RII;Primary end point(s): To determine the feasibility and safety of NGR-hTNF administered at low (0.8 &#956;g/m2) and high (45 &#956;g/m2) doses in combination with a standard oxaliplatin-based regimen in two sequential cohorts of patients with metastatic colorectal cancer.