Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer
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
1 other identifier
interventional
503
11 countries
95
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2006
Typical duration for phase_3
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2006
CompletedFirst Posted
Study publicly available on registry
April 7, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 23, 2017
March 1, 2017
3.2 years
April 5, 2006
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Time to tumor progression
46 weeks
Study Arms (2)
No Nadroparin
NO INTERVENTIONPatients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin
Nadroparin
EXPERIMENTALPatients will be randomized to receive standard anticancer treatment. Nadroparin patients will be treated with therapeutic doses of subcutaneous (s.c). nadroparin for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2-week periods of therapeutic doses of nadroparin 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 number of cycles achieved at that moment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (95)
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Antwerp, 2020, Belgium
GSK Investigational Site
Brasschaat, 2930, Belgium
GSK Investigational Site
Brussels, 1070, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
GSK Investigational Site
Brno, 612 00, Czechia
GSK Investigational Site
Prague, 120 00, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Prague, 150 08, Czechia
GSK Investigational Site
Prague, 180 00, Czechia
GSK Investigational Site
Příbram, 261 95, Czechia
GSK Investigational Site
Béthune, 62408, France
GSK Investigational Site
Clermont-Ferrand, 63000, France
GSK Investigational Site
Lille, 59000, France
GSK Investigational Site
Lyon, 69275, France
GSK Investigational Site
Marseille, 13005, France
GSK Investigational Site
Paris, 75010, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Paris, 75908, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Saint-Priest-en-Jarez, 42271, France
GSK Investigational Site
Strasbourg, 67085, France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Ebensfeld, Bavaria, 96250, Germany
GSK Investigational Site
Planegg, Bavaria, 82152, Germany
GSK Investigational Site
Bremen, City state Bremen, 28177, Germany
GSK Investigational Site
Hamburg, Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, Hamburg, 22081, Germany
GSK Investigational Site
Fulda, Hesse, 36043, Germany
GSK Investigational Site
Giessen, Hesse, 35392, Germany
GSK Investigational Site
Greifenstein, Hesse, 35753, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51067, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136, Germany
GSK Investigational Site
Herne, North Rhine-Westphalia, 44625, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06120, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104, Germany
GSK Investigational Site
Berlin, State of Berlin, 13353, Germany
GSK Investigational Site
Berlin, State of Berlin, 14165, Germany
GSK Investigational Site
Bad Berka, Thuringia, 99437, Germany
GSK Investigational Site
Budapest, 1106, Hungary
GSK Investigational Site
Budapest, 1125, Hungary
GSK Investigational Site
Budapest, 1529, Hungary
GSK Investigational Site
Győr, 9024, Hungary
GSK Investigational Site
Törökbálint, 2045, Hungary
GSK Investigational Site
Chieti Scalo, Abruzzo, 66013, Italy
GSK Investigational Site
Genoa, Liguria, 16128, Italy
GSK Investigational Site
Bergamo, Lombardy, 24128, Italy
GSK Investigational Site
Milan, Lombardy, 20142, Italy
GSK Investigational Site
Milan, Lombardy, 20153, Italy
GSK Investigational Site
Pavia, Lombardy, 27100, Italy
GSK Investigational Site
Campobasso, Molise, 86100, Italy
GSK Investigational Site
Florence, Tuscany, 50139, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Amsterdam, 1061 AE, Netherlands
GSK Investigational Site
Amsterdam, 1066 EC, Netherlands
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Delft, 2625 AD, Netherlands
GSK Investigational Site
Eindhoven, 5631 BM, Netherlands
GSK Investigational Site
Enschede, 7511JX, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Nijmegen, 6532 SZ, Netherlands
GSK Investigational Site
Rotterdam, 3078 HT, Netherlands
GSK Investigational Site
Sittard, 6131 BK, Netherlands
GSK Investigational Site
The Hague, 2545 CH, Netherlands
GSK Investigational Site
Winterswijk, 7101 BN, Netherlands
GSK Investigational Site
Zwolle, 8025 AB, Netherlands
GSK Investigational Site
Bialystok, 15-027, Poland
GSK Investigational Site
Krakow, 31-115, Poland
GSK Investigational Site
Lubin, 59-301, Poland
GSK Investigational Site
Olsztyn, 10-228, Poland
GSK Investigational Site
Olsztyn, 10-699, Poland
GSK Investigational Site
Warsaw, 00-909, Poland
GSK Investigational Site
Arkhangelsk, 163045, Russia
GSK Investigational Site
Kazan', 420111, Russia
GSK Investigational Site
Kirov, 610021, Russia
GSK Investigational Site
Moscow, 107005, Russia
GSK Investigational Site
Omsk, 644013, Russia
GSK Investigational Site
Orenburg, 460021, Russia
GSK Investigational Site
Saint Petersburg, 191104, Russia
GSK Investigational Site
Samara, 443066, Russia
GSK Investigational Site
Voronezh, 394062, Russia
GSK Investigational Site
Golnik, 4204, Slovenia
GSK Investigational Site
Ljubljana, 1000, Slovenia
Related 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.
PMID: 21502549BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2006
First Posted
April 7, 2006
Study Start
May 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.