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Completed

NCT Number: NCT00951574

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Oncology Department, Fabriano, Ancona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nadroparin calcium

Drug

Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

saline solution (placebo)

Drug

Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Italfarmaco

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Aug 4, 2009
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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