Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italfarmaco
• Treatments: Calcium; Calcium heparin; Calcium, Dietary; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Nadroparin

Criteria

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.