Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer

Thrombosis, Venous Clinical Trial

Official title:

A Randomized, Controlled Trial to Evaluate the Effects of Nadroparin on Survival and Disease Progression in Patients With Advanced Malignancies of the Lung, Pancreas, or Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312013
• Other study ID #: FRX106365
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2006
• Last updated: March 21, 2017
• Start date: May 2006
• Est. completion date: July 2009

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Hormone refractory prostate cancer within 6 months of diagnosis, OR locally advanced (non-metastasized) pancreatic cancer within 3 months of diagnosis, OR non-small-cell lung cancer within 3 months of stage IIIB.

Exclusion criteria:

• Life expectancy of <3 months.

• Poor performance status (Karnofsky <60).

• Need to be on anticoagulants.

• Use of nadroparin (a low molecular weight heparin) for any reason including a history of heparin-induced thrombocytopenia.

• Have brain metastasis.

• At a high risk of bleeding or have a platelet count <50,000/mm3.

• Have very poor kidney function.

Related Conditions & MeSH terms

• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

Intervention

Drug:
• Nadroparin
Patients will received all standard anti-cancer treatments. Therapeutic doses of nadroparin will be administered, subcutaneous for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2 week periods of therapeutic doses will be given for a total of 6 cycles each separated by a 4 week wash out. The study treatment period ends at week 46 regardless of the number of cycles achieved.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Brasschaat
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Roeselare
Canada	GSK Investigational Site	Toronto	Ontario
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Praha 2
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 8
Czech Republic	GSK Investigational Site	Pribram
France	GSK Investigational Site	Bethune Cedex
France	GSK Investigational Site	Clermont Ferrand
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 13
France	GSK Investigational Site	Paris Cedex 15
France	GSK Investigational Site	Pierre Benite
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Strasbourg
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Berka	Thueringen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bremen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ebensfeld	Bayern
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Freiburg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Fulda	Hessen
Germany	GSK Investigational Site	Giessen	Hessen
Germany	GSK Investigational Site	Greifenstein	Hessen
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Herne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Planegg	Bayern
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Törökbálint
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Campobasso	Molise
Italy	GSK Investigational Site	Chieti Scalo	Abruzzo
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Padova	Veneto
Italy	GSK Investigational Site	Pavia	Lombardia
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Delft
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Nieuwegein
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sittard
Netherlands	GSK Investigational Site	Winterswijk
Netherlands	GSK Investigational Site	Zwolle
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lubin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Warszawa
Russian Federation	GSK Investigational Site	Arkhangelsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Kirov
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Omsk
Russian Federation	GSK Investigational Site	Orenburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Voronezh
Slovenia	GSK Investigational Site	Golnik
Slovenia	GSK Investigational Site	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Slovenia, 

References & Publications (1)

van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).		AT least 46 weeks after randomization
Secondary	Time to tumor progression		46 weeks

External Links

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