Colon Cancer
Conditions
Keywords
NGR-hTNF, Capecitabine, Oxaliplatin, Colon cancer
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 cancer not amenable to any clinical improvement by current standard treatments
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 standard treatments are planned to be enrolled.
Interventions
DRUGNGR-hTNF
iv 0.8 or 45 mcg/sqm q3W
DRUGOxaliplatin
iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
DRUGcapecitabine
orally 825 mg/sqm 2qDx14
Sponsors
AGC Biologics S.p.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Document the preliminary antitumor activity in terms of objective response rate (according to RECIST criteria) and progression-free survival | during the study |
| Evaluate the pharmacokinetic profile of NGRhTNF and to measure plasma levels of sTNF-RI and sTNF-RII | before during and following the treatment |
Countries
Italy
Outcome results
None listed