Advanced Cancer, Metastatic Cancer
Conditions
Keywords
thromboembolism, cancer, chemotherapy, low-molecular-weight-heparin, nadroparin
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).
Interventions
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
Sponsors
Italfarmaco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Response to chemotherapy | Events occurring during the four months of treatment plus 10 days |
| 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 |
| Survival, at the end of study treatment | Events occurring during the four months of treatment plus 10 days |
| Asymptomatic thromboembolic events diagnosed during tests performed for other purposes | Events occurring during the four months of treatment plus 10 days |
| Safety (major bleeding, minor bleeding, other adverse events) | Events occurring during the four months of treatment plus 48 hours |
| Superficial thrombophlebitis of lower limbs | Events occurring during the four months of treatment plus 10 days |
Countries
Italy
Outcome results
None listed