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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 3
18 Years
N/A
Not Enrolling
Both
Advanced Cancer, Metastatic Cancer

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Trial Information

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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy

Outcome Time Frame:

Events occurring during the four months of treatment plus 10 days

Safety Issue:

No

Principal Investigator

Giancarlo Agnelli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Internal and Vascular Medicine University of Perigia (Italy)

Authority:

Italy: AIFA

Study ID:

DS/02/SELE/01

NCT ID:

NCT00951574

Start Date:

October 2003

Completion Date:

July 2008

Related Keywords:

  • Advanced Cancer
  • Metastatic Cancer
  • thromboembolism
  • cancer
  • chemotherapy
  • low-molecular-weight-heparin
  • nadroparin
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Thromboembolism

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