Status:
COMPLETED
NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00675012
Start Date
December 1 2007
End Date
May 1 2013
Last Update
May 30 2014
Active Locations (1)
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1
Azienda Ospedaliera Universitaria San Martino
Genoa, Genoa, Italy, 16132