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

Sponsor:	Italfarmaco
Collaborator:	Carlo Bianchini
Information provided by:	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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Calcium Cancer

Drug Information available for: Calcium gluconate Heparin

U.S. FDA Resources

Further study details as provided by Italfarmaco:

Primary Outcome Measures:

Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival, at the end of study treatment [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
Response to chemotherapy [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
Superficial thrombophlebitis of lower limbs [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
Asymptomatic thromboembolic events diagnosed during tests performed for other purposes [ Time Frame: Events occurring during the four months of treatment plus 10 days ] [ Designated as safety issue: No ]
Safety (major bleeding, minor bleeding, other adverse events) [ Time Frame: Events occurring during the four months of treatment plus 48 hours ] [ Designated as safety issue: Yes ]

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
saline solution: Placebo Comparator 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).
nadroparin calcium: Experimental 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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951574

Show 46 Study Locations

Sponsors and Collaborators

Italfarmaco

Carlo Bianchini

Investigators

Study Chair:

Giancarlo Agnelli, MD

Internal and Vascular Medicine University of Perigia (Italy)

More Information

No publications provided by Italfarmaco

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Agnelli G, Gussoni G, Bianchini C, Verso M, Mandalà M, Cavanna L, Barni S, Labianca R, Buzzi F, Scambia G, Passalacqua R, Ricci S, Gasparini G, Lorusso V, Bonizzoni E, Tonato M; PROTECHT Investigators. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncol. 2009 Oct;10(10):943-9. Epub 2009 Aug 31.

Responsible Party:	Italfarmaco S.p.A. ( Carlo Bianchini )
Study ID Numbers:	DS/02/SELE/01
Study First Received:	July 31, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00951574 History of Changes
Health Authority:	Italy: AIFA

Keywords provided by Italfarmaco:

thromboembolism
cancer
chemotherapy
low-molecular-weight-heparin
nadroparin

Additional relevant MeSH terms:

Anticoagulants
Nadroparin
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Physiological Effects of Drugs
Vascular Diseases
Fibrinolytic Agents
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Thromboembolism

Thrombosis
Calcium, Dietary
Fibrin Modulating Agents
Neoplastic Processes
Neoplasms
Embolism and Thrombosis
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on February 08, 2010