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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGC Biologics S.p.A.; MolMed S.p.A.
• Treatments: Capecitabine; Oxaliplatin

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