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

AGC Biologics

Status and phase

Completed

Phase 2

Conditions

Colon Cancer

Treatments

Drug: Oxaliplatin

Drug: NGR-hTNF

Drug: capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00675012

NGR005

2007-003668-24 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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