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| Sponsor: | Italfarmaco |
|---|---|
| Information provided by (Responsible Party): | Italfarmaco |
| ClinicalTrials.gov Identifier: | NCT00951574 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Metastatic Cancer |
Drug: Nadroparin calcium Drug: saline solution (placebo) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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. |
| Enrollment: | 1166 |
| Study Start Date: | October 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: saline solution
Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
|
Drug: saline solution (placebo)
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
|
|
Experimental: nadroparin calcium
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
|
Drug: Nadroparin calcium
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations| Italy | |
| Medical Oncology Department | |
| Fabriano, Ancona, Italy, 60044 | |
| Medical Oncology Department | |
| Treviglio, Bergamo, Italy, 24047 | |
| Casa Sollievo dell Sofferenza | |
| San Giovanni Rotondo, Foggia, Italy, 71013 | |
| Medical Oncology Department | |
| Taormina, Messina, Italy, 98039 | |
| Medical Oncology Department | |
| Legnano, Milano, Italy, 20025 | |
| Istituto Clinico Humanitas | |
| Rozzano, Milano, Italy, 20089 | |
| Medical Oncology Department | |
| Camposampiero, Padova, Italy, 35012 | |
| Medical Oncology Department | |
| Città di Castello, Perugia, Italy, 06012 | |
| Medical Oncology Department | |
| Todi, Perugia, Italy, 06059 | |
| Medical Oncology Department San Luigi Hospital | |
| Orbassano, Torino, Italy, 10043 | |
| Medical Oncology Department Oncology Institute | |
| Bari, Italy, 70126 | |
| Medical Oncology Unit | |
| Bergamo, Italy, 24100 | |
| Medical Oncology Department - Bellaria Hospital | |
| Bologna, Italy, 40139 | |
| Medical Oncology Department - Businco Hospital | |
| Cagliari, Italy, 09121 | |
| Medical Oncology Department University of Cagliari | |
| Cagliari, Italy, 09133 | |
| Medical Oncology Department | |
| Catanzaro, Italy, 88100 | |
| Medical Oncology Department | |
| Cosenza, Italy, 87100 | |
| Medical Oncology Department | |
| Cremona, Italy, 26100 | |
| Medical Oncology Department | |
| Ferrara, Italy, 44100 | |
| Medical Oncology Department Careggi Hospital | |
| Firenze, Italy, 50139 | |
| Cancer institute of Romagna | |
| Forlì, Italy, 47100 | |
| Medical Oncology Department | |
| Latina, Italy, 04100 | |
| Medical Oncology Department | |
| Lecce, Italy, 73100 | |
| Medical Oncology Department | |
| Lucca, Italy, 55100 | |
| Medical Oncology Department Policlinico | |
| Milano, Italy, 20122 | |
| Medical Oncology Department San Carlo Hospital | |
| Milano, Italy, 20153 | |
| Gynecology Oncology INT | |
| Milano, Italy, 20133 | |
| University Bicocca | |
| Milano, Italy, 20052 | |
| Medical Oncology Department Fatebenefratelli Hospital | |
| Milano, Italy, 20121 | |
| Medical Oncology Department Istituto Oncologico Veneto | |
| Padova, Italy, 35128 | |
| Medical Oncology Department | |
| Palermo, Italy, 90127 | |
| Salvatore Maugeri Foundation | |
| Pavia, Italy, 27100 | |
| Medical Oncology Department | |
| Perugia, Italy, 06156 | |
| Hematology and Oncology Department | |
| Piacenza, Italy, 29100 | |
| Medical Oncology Department - University of Pisa | |
| Pisa, Italy, 56126 | |
| Medical Oncology Department | |
| Ravenna, Italy, 48100 | |
| Medical Oncology Department | |
| Reggio Emilia, Italy, 42100 | |
| Medical Oncology Department - S Filippo Hospital | |
| Roma, Italy, 00135 | |
| Medical Oncology Department Regina Elena Institute | |
| Roma, Italy, 00144 | |
| Medical Oncology Department 3 Regina Elena Cancer Institute | |
| Rome, Italy, 00144 | |
| Onco-gynecology Department - Catholic University | |
| Rome, Italy, 00168 | |
| Medical Oncology Department | |
| Sassari, Italy, 07100 | |
| Medical Oncology Department | |
| Terni, Italy, 05100 | |
| Oncology Department Molinette Hospital | |
| Torino, Italy, 10126 | |
| Medical Oncology Department | |
| Varese, Italy, 21100 | |
| Medical Oncology Department | |
| Viterbo, Italy, 01100 | |
| Study Chair: | Giancarlo Agnelli, MD | Internal and Vascular Medicine University of Perigia (Italy) |
More Information
| Responsible Party: | Italfarmaco |
| ClinicalTrials.gov Identifier: | NCT00951574 History of Changes |
| Other Study ID Numbers: | DS/02/SELE/01 |
| Study First Received: | July 31, 2009 |
| Last Updated: | January 31, 2012 |
| Health Authority: | Italy: AIFA |
|
thromboembolism cancer chemotherapy low-molecular-weight-heparin nadroparin |
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Thromboembolism Neoplastic Processes Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Calcium, Dietary Heparin Heparin, Low-Molecular-Weight |
Dalteparin Nadroparin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Anticoagulants Hematologic Agents Therapeutic Uses Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |