Status:
COMPLETED
Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)
Lead Sponsor:
Italfarmaco
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 assi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
1166 Patients enrolled
Trial Details
Trial ID
NCT00951574
Start Date
October 1 2003
End Date
July 1 2008
Last Update
February 1 2012
Active Locations (46)
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1
Medical Oncology Department
Fabriano, Ancona, Italy, 60044
2
Medical Oncology Department Oncology Institute
Bari, Bari, Italy, 70126
3
Medical Oncology Unit
Bergamo, Bergamo, Italy, 24100
4
Medical Oncology Department
Treviglio, Bergamo, Italy, 24047