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

Metastatic Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951574
• Other study ID #: DS/02/SELE/01
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2009
• Last updated: January 31, 2012
• Start date: October 2003
• Est. completion date: July 2008

Study information

• Verified date: January 2012
• Source: Italfarmaco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1166
• Est. completion date: July 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Italy	Medical Oncology Department Oncology Institute	Bari
Italy	Medical Oncology Unit	Bergamo
Italy	Medical Oncology Department - Bellaria Hospital	Bologna
Italy	Medical Oncology Department - Businco Hospital	Cagliari
Italy	Medical Oncology Department University of Cagliari	Cagliari
Italy	Medical Oncology Department	Camposampiero	Padova
Italy	Medical Oncology Department	Catanzaro
Italy	Medical Oncology Department	Città di Castello	Perugia
Italy	Medical Oncology Department	Cosenza
Italy	Medical Oncology Department	Cremona
Italy	Medical Oncology Department	Fabriano	Ancona
Italy	Medical Oncology Department	Ferrara
Italy	Medical Oncology Department Careggi Hospital	Firenze
Italy	Cancer institute of Romagna	Forlì
Italy	Medical Oncology Department	Latina
Italy	Medical Oncology Department	Lecce
Italy	Medical Oncology Department	Legnano	Milano
Italy	Medical Oncology Department	Lucca
Italy	Gynecology Oncology INT	Milano
Italy	Medical Oncology Department Fatebenefratelli Hospital	Milano
Italy	Medical Oncology Department Policlinico	Milano
Italy	Medical Oncology Department San Carlo Hospital	Milano
Italy	University Bicocca	Milano
Italy	Medical Oncology Department San Luigi Hospital	Orbassano	Torino
Italy	Medical Oncology Department Istituto Oncologico Veneto	Padova
Italy	Medical Oncology Department	Palermo
Italy	Salvatore Maugeri Foundation	Pavia
Italy	Medical Oncology Department	Perugia
Italy	Hematology and Oncology Department	Piacenza
Italy	Medical Oncology Department - University of Pisa	Pisa
Italy	Medical Oncology Department	Ravenna
Italy	Medical Oncology Department	Reggio Emilia
Italy	Medical Oncology Department - S Filippo Hospital	Roma
Italy	Medical Oncology Department Regina Elena Institute	Roma
Italy	Medical Oncology Department 3 Regina Elena Cancer Institute	Rome
Italy	Onco-gynecology Department - Catholic University	Rome
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Casa Sollievo dell Sofferenza	San Giovanni Rotondo	Foggia
Italy	Medical Oncology Department	Sassari
Italy	Medical Oncology Department	Taormina	Messina
Italy	Medical Oncology Department	Terni
Italy	Medical Oncology Department	Todi	Perugia
Italy	Oncology Department Molinette Hospital	Torino
Italy	Medical Oncology Department	Treviglio	Bergamo
Italy	Medical Oncology Department	Varese
Italy	Medical Oncology Department	Viterbo

Sponsors (1)

Lead Sponsor	Collaborator
Italfarmaco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy		Events occurring during the four months of treatment plus 10 days	No
Secondary	Survival, at the end of study treatment		Events occurring during the four months of treatment plus 10 days	No
Secondary	Response to chemotherapy		Events occurring during the four months of treatment plus 10 days	No
Secondary	For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal		Events occurring during the four months of treatment plus 10 days	No
Secondary	Superficial thrombophlebitis of lower limbs		Events occurring during the four months of treatment plus 10 days	No
Secondary	Asymptomatic thromboembolic events diagnosed during tests performed for other purposes		Events occurring during the four months of treatment plus 10 days	No
Secondary	Safety (major bleeding, minor bleeding, other adverse events)		Events occurring during the four months of treatment plus 48 hours	Yes