Title
Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)
Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium). A Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study.
Phase
Phase 3Lead Sponsor
ItalfarmacoStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Advanced Cancer Metastatic CancerIntervention/Treatment
sodium chloride nadroparin ...Study Participants
1166In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
INCLUSION CRITERIA: both sexes;aged>18 years; suffering from different types of malignancies(lung, breast,gastric,colon- rectum,pancreatic,ovarian,head and neck cancer)undergoing systemic chemotherapy, having signed Informed Consent prior to initiation of any study procedure. EXCLUSION CRITERIA: adjuvant and neo-adjuvant chemotherapy; objectively confirmed venous or arterial thromboembolism in the last three months; antithrombotic treatment for other indications; life expectancy of less than 3 months; Performance Status>2(ECOG); active bleeding or bleedings in the last four weeks requiring hospitalization,transfusion or surgical intervention; bleeding diathesis(prothrombin time<70% or activated partial thromboplastin time ratio>1.3),or platelet count<50x10^9/L; cerebrovascular hemorrhage in the last six months; known active gastric or duodenal ulcer; known cerebral metastasis; cerebral aneurysm; III-IV grade diabetic retinopathy; severe and uncontrolled hypertension(systolic blood pressure>180 mmHg or diastolic blood pressure>110 mmHg); chronic atrial fibrillation; acute endocarditis; acute pancreatitis; known hypersensitivity to unfractionated heparin or LMWH; previous occurrence of heparin-induced thrombocytopenia; renal impairment (dependent on dialysis or creatinine higher than 2.5mg%); liver insufficiency (alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase levels>3 times the upper limit of the normal ranges and/or total bilirubin >3.0 mg/ml); pregnancy or childbearing potential without adequate contraception; treatment with other investigational drugs or patient inclusion in other clinical trials; patients who are unable to fulfill the study requirements in terms of visits/compliance to treatment.