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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00951574
Other study ID # DS/02/SELE/01
Secondary ID
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


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
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