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

NCT ID: NCT00951574

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2008-07-31

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).

Conditions

Advanced Cancer; Metastatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

saline solution

Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).

Group Type: PLACEBO_COMPARATOR

saline solution (placebo)

Intervention Type: DRUG

Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).

nadroparin calcium

Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

Group Type: EXPERIMENTAL

Nadroparin calcium

Intervention Type: DRUG

Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

Interventions

Nadroparin calcium

Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).

Intervention Type: DRUG

saline solution (placebo)

Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italfarmaco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giancarlo Agnelli, MD

Role: STUDY_CHAIR

Internal and Vascular Medicine University of Perigia (Italy)

Locations

Medical Oncology Department

Fabriano, Ancona, Italy

Medical Oncology Department Oncology Institute

Bari, Bari, Italy

Medical Oncology Unit

Bergamo, Bergamo, Italy

Medical Oncology Department

Treviglio, Bergamo, Italy

Medical Oncology Department - Bellaria Hospital

Bologna, Bologna, Italy

Medical Oncology Department - Businco Hospital

Cagliari, Cagliari, Italy

Medical Oncology Department University of Cagliari

Cagliari, Cagliari, Italy

Medical Oncology Department

Catanzaro, Catanzaro, Italy

Medical Oncology Department

Cosenza, Cosenza, Italy

Medical Oncology Department

Cremona, Cremona, Italy

Medical Oncology Department

Ferrara, Ferrara, Italy

Medical Oncology Department Careggi Hospital

Florence, Firenze, Italy

Casa Sollievo dell Sofferenza

San Giovanni Rotondo, Foggia, Italy

Cancer institute of Romagna

Forlì, Forlì, Italy

Medical Oncology Department

Latina, Latina, Italy

Medical Oncology Department

Lecce, Lecce, Italy

Medical Oncology Department

Lucca, Lucca, Italy

Medical Oncology Department

Taormina, Messina, Italy

Medical Oncology Department

Legnano, Milano, Italy

University Bicocca

Milan, Milano, Italy

Medical Oncology Department Fatebenefratelli Hospital

Milan, Milano, Italy

Medical Oncology Department Policlinico

Milan, Milano, Italy

Gynecology Oncology INT

Milan, Milano, Italy

Medical Oncology Department San Carlo Hospital

Milan, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Medical Oncology Department

Camposampiero, Padova, Italy

Medical Oncology Department Istituto Oncologico Veneto

Padua, Padova, Italy

Medical Oncology Department

Palermo, Palermo, Italy

Salvatore Maugeri Foundation

Pavia, Pavia, Italy

Medical Oncology Department

Città di Castello, Perugia, Italy

Medical Oncology Department

Perugia, Perugia, Italy

Medical Oncology Department

Todi, Perugia, Italy

Hematology and Oncology Department

Piacenza, Piacenza, Italy

Medical Oncology Department - University of Pisa

Pisa, Pisa, Italy

Medical Oncology Department

Ravenna, Ravenna, Italy

Medical Oncology Department

Reggio Emilia, Reggio Emilia, Italy

Medical Oncology Department - S Filippo Hospital

Roma, Roma, Italy

Medical Oncology Department Regina Elena Institute

Roma, Roma, Italy

Medical Oncology Department 3 Regina Elena Cancer Institute

Rome, Rome, Italy

Onco-gynecology Department - Catholic University

Rome, Rome, Italy

Medical Oncology Department

Sassari, Sassari, Italy

Medical Oncology Department

Terni, Terni, Italy

Medical Oncology Department San Luigi Hospital

Orbassano, Torino, Italy

Oncology Department Molinette Hospital

Torino, Torino, Italy

Medical Oncology Department

Varese, Varese, Italy

Medical Oncology Department

Viterbo, Viterbo, Italy

Countries

Italy

References

Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

Reference Type: DERIVED

PMID: 33337539 (View on PubMed)

Barni S, Labianca R, Agnelli G, Bonizzoni E, Verso M, Mandala M, Brighenti M, Petrelli F, Bianchini C, Perrone T, Gasparini G. Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study. J Transl Med. 2011 Oct 20;9:179. doi: 10.1186/1479-5876-9-179.

Reference Type: DERIVED

PMID: 22013950 (View on PubMed)

Agnelli G, Gussoni G, Bianchini C, Verso M, Mandala 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. doi: 10.1016/S1470-2045(09)70232-3. Epub 2009 Aug 31.

Reference Type: DERIVED

PMID: 19726226 (View on PubMed)

Other Identifiers

DS/02/SELE/01

Identifier Type: -

Identifier Source: org_study_id