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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Italfarmaco
ClinicalTrials.gov Identifier:
NCT00951574
First received: July 31, 2009
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Advanced Cancer
Metastatic Cancer
Drug: Nadroparin calcium
Drug: saline solution (placebo)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Italfarmaco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival, at the end of study treatment [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
  • Response to chemotherapy [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Superficial thrombophlebitis of lower limbs [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
  • Asymptomatic thromboembolic events diagnosed during tests performed for other purposes [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
  • Safety (major bleeding, minor bleeding, other adverse events) [ Time Frame: Events occurring during the four months of treatment plus 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 1166
Study Start Date: October 2003
Study Completion Date: July 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951574

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

No publications provided by Italfarmaco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Italfarmaco
ClinicalTrials.gov Identifier: NCT00951574     History of Changes
Other Study ID Numbers: DS/02/SELE/01
Study First Received: July 31, 2009
Last Updated: January 31, 2012
Health Authority: Italy: AIFA

Keywords provided by Italfarmaco:
thromboembolism
cancer
chemotherapy
low-molecular-weight-heparin
nadroparin

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Thromboembolism
Neoplastic Processes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Calcium, Dietary
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Nadroparin
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 14, 2014