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

Italfarmaco

Status and phase

Completed

Phase 3

Conditions

Metastatic Cancer

Advanced Cancer

Treatments

Drug: saline solution (placebo)

Drug: Nadroparin calcium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00951574

DS/02/SELE/01

Details and patient eligibility

About

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).

Enrollment

1,166 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.