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

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ClinicalTrials.gov Identifier: NCT00951574
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Italfarmaco

Study Description
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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 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 or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Drug: Nadroparin calcium Drug: saline solution (placebo) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1166 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : October 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2008

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Survival, at the end of study treatment [ Time Frame: Events occurring during the four months of treatment plus 10 days ]
  2. Response to chemotherapy [ Time Frame: Events occurring during the four months of treatment plus 10 days ]
  3. 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 ]
  4. Superficial thrombophlebitis of lower limbs [ Time Frame: Events occurring during the four months of treatment plus 10 days ]
  5. Asymptomatic thromboembolic events diagnosed during tests performed for other purposes [ Time Frame: Events occurring during the four months of treatment plus 10 days ]
  6. Safety (major bleeding, minor bleeding, other adverse events) [ Time Frame: Events occurring during the four months of treatment plus 48 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951574


Locations
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Sponsors and Collaborators
Italfarmaco
Investigators
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Study Chair: Giancarlo Agnelli, MD Internal and Vascular Medicine University of Perigia (Italy)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Italfarmaco
ClinicalTrials.gov Identifier: NCT00951574    
Other Study ID Numbers: DS/02/SELE/01
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012
Keywords provided by Italfarmaco:
thromboembolism
cancer
chemotherapy
low-molecular-weight-heparin
nadroparin
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Nadroparin
Calcium
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action