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

NCT00951574 | Completed Phase 3 DMC

• 1 other identifier: DS/02/SELE/01
• Study Type: interventional
• Target: 1,166
• Locations: 1 country
• Sites: 46

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

Keywords

thromboembolism; cancer; chemotherapy; low-molecular-weight-heparin; nadroparin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Survival, at the end of study treatment

  Events occurring during the four months of treatment plus 10 days

• 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

• Superficial thrombophlebitis of lower limbs

  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

Study Arms (2)

saline solution

PLACEBO COMPARATOR

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

Drug: saline solution (placebo)

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

Interventions

Nadroparin calcium DRUG

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

nadroparin calcium

saline solution (placebo) DRUG

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

saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Italfarmaco: lead

Study Sites (46)

Medical Oncology Department

Fabriano, Ancona, 60044, Italy

Location

Medical Oncology Department Oncology Institute

Bari, Bari, 70126, Italy

Location

Medical Oncology Unit

Bergamo, Bergamo, 24100, Italy

Location

Medical Oncology Department

Treviglio, Bergamo, 24047, Italy

Location

Medical Oncology Department - Bellaria Hospital

Bologna, Bologna, 40139, Italy

Location

Medical Oncology Department - Businco Hospital

Cagliari, Cagliari, 09121, Italy

Location

Medical Oncology Department University of Cagliari

Cagliari, Cagliari, 09133, Italy

Location

Medical Oncology Department

Catanzaro, Catanzaro, 88100, Italy

Location

Medical Oncology Department

Cosenza, Cosenza, 87100, Italy

Location

Medical Oncology Department

Cremona, Cremona, 26100, Italy

Location

Medical Oncology Department

Ferrara, Ferrara, 44100, Italy

Location

Medical Oncology Department Careggi Hospital

Florence, Firenze, 50139, Italy

Location

Casa Sollievo dell Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Cancer institute of Romagna

Forlì, Forlì, 47100, Italy

Location

Medical Oncology Department

Latina, Latina, 04100, Italy

Location

Medical Oncology Department

Lecce, Lecce, 73100, Italy

Location

Medical Oncology Department

Lucca, Lucca, 55100, Italy

Location

Medical Oncology Department

Taormina, Messina, 98039, Italy

Location

Medical Oncology Department

Legnano, Milano, 20025, Italy

Location

University Bicocca

Milan, Milano, 20052, Italy

Location

Medical Oncology Department Fatebenefratelli Hospital

Milan, Milano, 20121, Italy

Location

Medical Oncology Department Policlinico

Milan, Milano, 20122, Italy

Location

Gynecology Oncology INT

Milan, Milano, 20133, Italy

Location

Medical Oncology Department San Carlo Hospital

Milan, Milano, 20153, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Medical Oncology Department

Camposampiero, Padova, 35012, Italy

Location

Medical Oncology Department Istituto Oncologico Veneto

Padua, Padova, 35128, Italy

Location

Medical Oncology Department

Palermo, Palermo, 90127, Italy

Location

Salvatore Maugeri Foundation

Pavia, Pavia, 27100, Italy

Location

Medical Oncology Department

Città di Castello, Perugia, 06012, Italy

Location

Medical Oncology Department

Perugia, Perugia, 06156, Italy

Location

Medical Oncology Department

Todi, Perugia, 06059, Italy

Location

Hematology and Oncology Department

Piacenza, Piacenza, 29100, Italy

Location

Medical Oncology Department - University of Pisa

Pisa, Pisa, 56126, Italy

Location

Medical Oncology Department

Ravenna, Ravenna, 48100, Italy

Location

Medical Oncology Department

Reggio Emilia, Reggio Emilia, 42100, Italy

Location

Medical Oncology Department - S Filippo Hospital

Roma, Roma, 00135, Italy

Location

Medical Oncology Department Regina Elena Institute

Roma, Roma, 00144, Italy

Location

Medical Oncology Department 3 Regina Elena Cancer Institute

Rome, Rome, 00144, Italy

Location

Onco-gynecology Department - Catholic University

Rome, Rome, 00168, Italy

Location

Medical Oncology Department

Sassari, Sassari, 07100, Italy

Location

Medical Oncology Department

Terni, Terni, 05100, Italy

Location

Medical Oncology Department San Luigi Hospital

Orbassano, Torino, 10043, Italy

Location

Oncology Department Molinette Hospital

Torino, Torino, 10126, Italy

Location

Medical Oncology Department

Varese, Varese, 21100, Italy

Location

Medical Oncology Department

Viterbo, Viterbo, 01100, Italy

Location

Related Publications (3)

• 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.

  PMID: 33337539 DERIVED

• 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.

  PMID: 22013950 DERIVED

• 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.

  PMID: 19726226 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Thromboembolism; Neoplasms

Interventions

Nadroparin; Saline Solution

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Giancarlo Agnelli, MD

  Internal and Vascular Medicine University of Perigia (Italy)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: October 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: July 1, 2008
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

IT (46)