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

January 31, 2012 updated by: Italfarmaco

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1166

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70126
        • Medical Oncology Department Oncology Institute
      • Bergamo, Italy, 24100
        • Medical Oncology Unit
      • Bologna, Italy, 40139
        • Medical Oncology Department - Bellaria Hospital
      • Cagliari, Italy, 09121
        • Medical Oncology Department - Businco Hospital
      • Cagliari, Italy, 09133
        • Medical Oncology Department University of Cagliari
      • Catanzaro, Italy, 88100
        • Medical Oncology Department
      • Cosenza, Italy, 87100
        • Medical Oncology Department
      • Cremona, Italy, 26100
        • Medical Oncology Department
      • Ferrara, Italy, 44100
        • Medical Oncology Department
      • Firenze, Italy, 50139
        • Medical Oncology Department Careggi Hospital
      • Forlì, Italy, 47100
        • Cancer institute of Romagna
      • Latina, Italy, 04100
        • Medical Oncology Department
      • Lecce, Italy, 73100
        • Medical Oncology Department
      • Lucca, Italy, 55100
        • Medical Oncology Department
      • Milano, Italy, 20052
        • University Bicocca
      • Milano, Italy, 20121
        • Medical Oncology Department Fatebenefratelli Hospital
      • Milano, Italy, 20122
        • Medical Oncology Department Policlinico
      • Milano, Italy, 20133
        • Gynecology Oncology INT
      • Milano, Italy, 20153
        • Medical Oncology Department San Carlo Hospital
      • Padova, Italy, 35128
        • Medical Oncology Department Istituto Oncologico Veneto
      • Palermo, Italy, 90127
        • Medical Oncology Department
      • Pavia, Italy, 27100
        • Salvatore Maugeri Foundation
      • Perugia, Italy, 06156
        • Medical Oncology Department
      • Piacenza, Italy, 29100
        • Hematology and Oncology Department
      • Pisa, Italy, 56126
        • Medical Oncology Department - University of Pisa
      • Ravenna, Italy, 48100
        • Medical Oncology Department
      • Reggio Emilia, Italy, 42100
        • Medical Oncology Department
      • Roma, Italy, 00135
        • Medical Oncology Department - S Filippo Hospital
      • Roma, Italy, 00144
        • Medical Oncology Department Regina Elena Institute
      • Rome, Italy, 00144
        • Medical Oncology Department 3 Regina Elena Cancer Institute
      • Rome, Italy, 00168
        • Onco-gynecology Department - Catholic University
      • Sassari, Italy, 07100
        • Medical Oncology Department
      • Terni, Italy, 05100
        • Medical Oncology Department
      • Torino, Italy, 10126
        • Oncology Department Molinette Hospital
      • Varese, Italy, 21100
        • Medical Oncology Department
      • Viterbo, Italy, 01100
        • Medical Oncology Department
    • Ancona
      • Fabriano, Ancona, Italy, 60044
        • Medical Oncology Department
    • Bergamo
      • Treviglio, Bergamo, Italy, 24047
        • Medical Oncology Department
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Casa Sollievo dell Sofferenza
    • Messina
      • Taormina, Messina, Italy, 98039
        • Medical Oncology Department
    • Milano
      • Legnano, Milano, Italy, 20025
        • Medical Oncology Department
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
    • Padova
      • Camposampiero, Padova, Italy, 35012
        • Medical Oncology Department
    • Perugia
      • Città di Castello, Perugia, Italy, 06012
        • Medical Oncology Department
      • Todi, Perugia, Italy, 06059
        • Medical Oncology Department
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Medical Oncology Department San Luigi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: saline solution
Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
Drug: saline solution (placebo)
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
EXPERIMENTAL: nadroparin calcium
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Drug: Nadroparin calcium
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival, at the end of study treatment
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days
Response to chemotherapy
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days
For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days
Superficial thrombophlebitis of lower limbs
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days
Asymptomatic thromboembolic events diagnosed during tests performed for other purposes
Time Frame: Events occurring during the four months of treatment plus 10 days
Events occurring during the four months of treatment plus 10 days
Safety (major bleeding, minor bleeding, other adverse events)
Time Frame: Events occurring during the four months of treatment plus 48 hours
Events occurring during the four months of treatment plus 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italfarmaco

Investigators

  • Study Chair: Giancarlo Agnelli, MD, Internal and Vascular Medicine University of Perigia (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS/02/SELE/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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