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

Primary Purpose

Advanced Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Nadroparin calcium
saline solution (placebo)
Sponsored by
Italfarmaco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Advanced Cancer focused on measuring thromboembolism, cancer, chemotherapy, low-molecular-weight-heparin, nadroparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Oncology Department
  • Medical Oncology Department
  • Casa Sollievo dell Sofferenza
  • Medical Oncology Department
  • Medical Oncology Department
  • Istituto Clinico Humanitas
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department San Luigi Hospital
  • Medical Oncology Department Oncology Institute
  • Medical Oncology Unit
  • Medical Oncology Department - Bellaria Hospital
  • Medical Oncology Department - Businco Hospital
  • Medical Oncology Department University of Cagliari
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department Careggi Hospital
  • Cancer institute of Romagna
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department
  • University Bicocca
  • Medical Oncology Department Fatebenefratelli Hospital
  • Medical Oncology Department Policlinico
  • Gynecology Oncology INT
  • Medical Oncology Department San Carlo Hospital
  • Medical Oncology Department Istituto Oncologico Veneto
  • Medical Oncology Department
  • Salvatore Maugeri Foundation
  • Medical Oncology Department
  • Hematology and Oncology Department
  • Medical Oncology Department - University of Pisa
  • Medical Oncology Department
  • Medical Oncology Department
  • Medical Oncology Department - S Filippo Hospital
  • Medical Oncology Department Regina Elena Institute
  • Medical Oncology Department 3 Regina Elena Cancer Institute
  • Onco-gynecology Department - Catholic University
  • Medical Oncology Department
  • Medical Oncology Department
  • Oncology Department Molinette Hospital
  • Medical Oncology Department
  • Medical Oncology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

saline solution

nadroparin calcium

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival, at the end of study treatment
Response to chemotherapy
For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal
Superficial thrombophlebitis of lower limbs
Asymptomatic thromboembolic events diagnosed during tests performed for other purposes
Safety (major bleeding, minor bleeding, other adverse events)

Full Information

First Posted
July 31, 2009
Last Updated
January 31, 2012
Sponsor
Italfarmaco
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1. Study Identification

Unique Protocol Identification Number
NCT00951574
Brief Title
Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italfarmaco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Metastatic Cancer
Keywords
thromboembolism, cancer, chemotherapy, low-molecular-weight-heparin, nadroparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline solution
Arm Type
Placebo Comparator
Arm Description
Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
Arm Title
nadroparin calcium
Arm Type
Experimental
Arm Description
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Intervention Type
Drug
Intervention Name(s)
Nadroparin calcium
Intervention Description
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Intervention Type
Drug
Intervention Name(s)
saline solution (placebo)
Intervention Description
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Survival, at the end of study treatment
Time Frame
Events occurring during the four months of treatment plus 10 days
Title
Response to chemotherapy
Time Frame
Events occurring during the four months of treatment plus 10 days
Title
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
Title
Superficial thrombophlebitis of lower limbs
Time Frame
Events occurring during the four months of treatment plus 10 days
Title
Asymptomatic thromboembolic events diagnosed during tests performed for other purposes
Time Frame
Events occurring during the four months of treatment plus 10 days
Title
Safety (major bleeding, minor bleeding, other adverse events)
Time Frame
Events occurring during the four months of treatment plus 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giancarlo Agnelli, MD
Organizational Affiliation
Internal and Vascular Medicine University of Perigia (Italy)
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Oncology Department
City
Fabriano
State/Province
Ancona
ZIP/Postal Code
60044
Country
Italy
Facility Name
Medical Oncology Department
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Casa Sollievo dell Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Medical Oncology Department
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Medical Oncology Department
City
Legnano
State/Province
Milano
ZIP/Postal Code
20025
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Medical Oncology Department
City
Camposampiero
State/Province
Padova
ZIP/Postal Code
35012
Country
Italy
Facility Name
Medical Oncology Department
City
Città di Castello
State/Province
Perugia
ZIP/Postal Code
06012
Country
Italy
Facility Name
Medical Oncology Department
City
Todi
State/Province
Perugia
ZIP/Postal Code
06059
Country
Italy
Facility Name
Medical Oncology Department San Luigi Hospital
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Medical Oncology Department Oncology Institute
City
Bari
ZIP/Postal Code
70126
Country
Italy
Facility Name
Medical Oncology Unit
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Medical Oncology Department - Bellaria Hospital
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Medical Oncology Department - Businco Hospital
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Medical Oncology Department University of Cagliari
City
Cagliari
ZIP/Postal Code
09133
Country
Italy
Facility Name
Medical Oncology Department
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Medical Oncology Department
City
Cosenza
ZIP/Postal Code
87100
Country
Italy
Facility Name
Medical Oncology Department
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Medical Oncology Department
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Medical Oncology Department Careggi Hospital
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Cancer institute of Romagna
City
Forlì
ZIP/Postal Code
47100
Country
Italy
Facility Name
Medical Oncology Department
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Medical Oncology Department
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Medical Oncology Department
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
University Bicocca
City
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
Medical Oncology Department Fatebenefratelli Hospital
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Medical Oncology Department Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Gynecology Oncology INT
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Medical Oncology Department San Carlo Hospital
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Medical Oncology Department Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Medical Oncology Department
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Salvatore Maugeri Foundation
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Medical Oncology Department
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Hematology and Oncology Department
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Medical Oncology Department - University of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Medical Oncology Department
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Medical Oncology Department
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Medical Oncology Department - S Filippo Hospital
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Medical Oncology Department Regina Elena Institute
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Medical Oncology Department 3 Regina Elena Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Onco-gynecology Department - Catholic University
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Medical Oncology Department
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Medical Oncology Department
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Oncology Department Molinette Hospital
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Medical Oncology Department
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Medical Oncology Department
City
Viterbo
ZIP/Postal Code
01100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33337539
Citation
Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
Results Reference
derived
PubMed Identifier
22013950
Citation
Barni S, Labianca R, Agnelli G, Bonizzoni E, Verso M, Mandala M, Brighenti M, Petrelli F, Bianchini C, Perrone T, Gasparini G. Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study. J Transl Med. 2011 Oct 20;9:179. doi: 10.1186/1479-5876-9-179.
Results Reference
derived
PubMed Identifier
19726226
Citation
Agnelli G, Gussoni G, Bianchini C, Verso M, Mandala M, Cavanna L, Barni S, Labianca R, Buzzi F, Scambia G, Passalacqua R, Ricci S, Gasparini G, Lorusso V, Bonizzoni E, Tonato M; PROTECHT Investigators. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncol. 2009 Oct;10(10):943-9. doi: 10.1016/S1470-2045(09)70232-3. Epub 2009 Aug 31.
Results Reference
derived

Learn more about this trial

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

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