Colon Cancer Clinical Trial
Official title:
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
Verified date | May 2014 |
Source | MolMed S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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
Status | Completed |
Enrollment | 24 |
Est. completion date | May 2013 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria San Martino | Genoa |
Lead Sponsor | Collaborator |
---|---|
MolMed S.p.A. |
Italy,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | during the study | Yes | |
Secondary | Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival | during the study | No | |
Secondary | Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII | before during and following the treatment | No |
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