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.
Verified date | January 2012 |
Source | Italfarmaco |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: AIFA |
Study type | Interventional |
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).
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Italfarmaco |
Italy,
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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