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Advanced CancerPhase 3NCT00951574

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

A Phase 3 study testing Nadroparin calcium in people with Advanced Cancer and Metastatic Cancer, run by Italfarmaco at 46 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer
What is being tested?
Nadroparin calcium
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,166 participants
Where
46 sitesItaly
Study dates
Oct 2003to Jul 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 23Show fewer
  • 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.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Italy46 sites

  • Medical Oncology Department Oncology Institute

    Bari, Bari, 70126

  • Medical Oncology Unit

    Bergamo, Bergamo, 24100

  • Medical Oncology Department - Bellaria Hospital

    Bologna, Bologna, 40139

  • Medical Oncology Department - Businco Hospital

    Cagliari, Cagliari, 09121

  • Medical Oncology Department University of Cagliari

    Cagliari, Cagliari, 09133

  • Medical Oncology Department

    Camposampiero, Padova, 35012

  • Medical Oncology Department

    Catanzaro, Catanzaro, 88100

  • Medical Oncology Department

    Città di Castello, Perugia, 06012

  • Medical Oncology Department

    Cosenza, Cosenza, 87100

  • Medical Oncology Department

    Cremona, Cremona, 26100

  • Medical Oncology Department

    Fabriano, Ancona, 60044

  • Medical Oncology Department

    Ferrara, Ferrara, 44100

  • Medical Oncology Department Careggi Hospital

    Florence, Firenze, 50139

  • Cancer institute of Romagna

    Forlì, Forlì, 47100

  • Medical Oncology Department

    Latina, Latina, 04100

  • Medical Oncology Department

    Lecce, Lecce, 73100

  • Medical Oncology Department

    Legnano, Milano, 20025

  • Medical Oncology Department

    Lucca, Lucca, 55100

  • University Bicocca

    Milan, Milano, 20052

  • Medical Oncology Department Fatebenefratelli Hospital

    Milan, Milano, 20121

  • Medical Oncology Department Policlinico

    Milan, Milano, 20122

  • Gynecology Oncology INT

    Milan, Milano, 20133

  • Medical Oncology Department San Carlo Hospital

    Milan, Milano, 20153

  • Medical Oncology Department San Luigi Hospital

    Orbassano, Torino, 10043

  • Medical Oncology Department Istituto Oncologico Veneto

    Padova, Padova, 35128

  • Medical Oncology Department

    Palermo, Palermo, 90127

  • Salvatore Maugeri Foundation

    Pavia, Pavia, 27100

  • Medical Oncology Department

    Perugia, Perugia, 06156

  • Hematology and Oncology Department

    Piacenza, Piacenza, 29100

  • Medical Oncology Department - University of Pisa

    Pisa, Pisa, 56126

  • Medical Oncology Department

    Ravenna, Ravenna, 48100

  • Medical Oncology Department

    Reggio Emilia, Reggio Emilia, 42100

  • Medical Oncology Department - S Filippo Hospital

    Roma, Roma, 00135

  • Medical Oncology Department Regina Elena Institute

    Roma, Roma, 00144

  • Medical Oncology Department 3 Regina Elena Cancer Institute

    Rome, Rome, 00144

  • Onco-gynecology Department - Catholic University

    Rome, Rome, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Casa Sollievo dell Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Medical Oncology Department

    Sassari, Sassari, 07100

  • Medical Oncology Department

    Taormina, Messina, 98039

  • Medical Oncology Department

    Terni, Terni, 05100

  • Medical Oncology Department

    Todi, Perugia, 06059

  • Oncology Department Molinette Hospital

    Torino, Torino, 10126

  • Medical Oncology Department

    Treviglio, Bergamo, 24047

  • Medical Oncology Department

    Varese, Varese, 21100

  • Medical Oncology Department

    Viterbo, Viterbo, 01100

Other trials in Italy

About this 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.

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).

Being tested
Nadroparin calcium, saline solution (placebo)
Keywords
thromboembolism, cancer, chemotherapy, low-molecular-weight-heparin, nadroparin
Medical subject headings
Neoplasm Metastasis, Thromboembolism, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nadroparin calciumDrug

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

  • saline solution (placebo)Drug

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

Study groups in NCT00951574
Study groupRoleWhat they receive
saline solutionPlacebo comparatorPre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours).
Receives: Drug: saline solution (placebo)
nadroparin calciumExperimentalNadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Receives: Drug: Nadroparin calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy

    Measured: Events occurring during the four months of treatment plus 10 days

Secondary outcomes (6)

  1. Survival, at the end of study treatment

    Measured: Events occurring during the four months of treatment plus 10 days

  2. Response to chemotherapy

    Measured: Events occurring during the four months of treatment plus 10 days

  3. For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal

    Measured: Events occurring during the four months of treatment plus 10 days

  4. Superficial thrombophlebitis of lower limbs

    Measured: Events occurring during the four months of treatment plus 10 days

  5. Asymptomatic thromboembolic events diagnosed during tests performed for other purposes

    Measured: Events occurring during the four months of treatment plus 10 days

  6. Safety (major bleeding, minor bleeding, other adverse events)

    Measured: Events occurring during the four months of treatment plus 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2009 (estimated)
  2. Study startOct 2003
  3. Primary completionMay 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00951574
Sponsor's protocol ID
DS/02/SELE/01
Status last verified
Jan 2012
First submitted
31 Jul 2009
Last updated
1 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33337539

  • 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.

    PubMed 22013950

  • 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.

    PubMed 19726226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nadroparin calcium in people with Advanced Cancer and Metastatic Cancer, run by Italfarmaco at 46 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00951574, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.

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