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.

In 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).

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.