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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00312013
Collaborator
(none)
503
Enrollment
95
Locations
2
Arms
38
Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
503 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Nadroparin

Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin
Experimental: Nadroparin

Patients 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.

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.

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Time to tumor progression [46 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Aalst Belgium 9300
2 GSK Investigational Site Antwerpen Belgium 2020
3 GSK Investigational Site Brasschaat Belgium 2930
4 GSK Investigational Site Bruxelles Belgium 1070
5 GSK Investigational Site Bruxelles Belgium 1200
6 GSK Investigational Site Liège Belgium 4000
7 GSK Investigational Site Roeselare Belgium 8800
8 GSK Investigational Site Toronto Ontario Canada M4N 3M5
9 GSK Investigational Site Brno Czech Republic 612 00
10 GSK Investigational Site Praha 2 Czech Republic 120 00
11 GSK Investigational Site Praha 5 Czech Republic 150 06
12 GSK Investigational Site Praha 5 Czech Republic 150 08
13 GSK Investigational Site Praha 8 Czech Republic 180 00
14 GSK Investigational Site Pribram Czech Republic 261 95
15 GSK Investigational Site Bethune Cedex France 62408
16 GSK Investigational Site Clermont Ferrand France 63000
17 GSK Investigational Site Lille France 59000
18 GSK Investigational Site Lyon France 69275
19 GSK Investigational Site Marseille France 13005
20 GSK Investigational Site Paris Cedex 13 France 75651
21 GSK Investigational Site Paris Cedex 15 France 75908
22 GSK Investigational Site Paris France 75010
23 GSK Investigational Site Paris France 75015
24 GSK Investigational Site Pierre Benite France 69495
25 GSK Investigational Site Saint-Priest en Jarez France 42271
26 GSK Investigational Site Strasbourg France 67085
27 GSK Investigational Site Freiburg Baden-Wuerttemberg Germany 79106
28 GSK Investigational Site Heidelberg Baden-Wuerttemberg Germany 69120
29 GSK Investigational Site Mannheim Baden-Wuerttemberg Germany 68167
30 GSK Investigational Site Augsburg Bayern Germany 86150
31 GSK Investigational Site Ebensfeld Bayern Germany 96250
32 GSK Investigational Site Planegg Bayern Germany 82152
33 GSK Investigational Site Fulda Hessen Germany 36043
34 GSK Investigational Site Giessen Hessen Germany 35392
35 GSK Investigational Site Greifenstein Hessen Germany 35753
36 GSK Investigational Site Hannover Niedersachsen Germany 30625
37 GSK Investigational Site Duesseldorf Nordrhein-Westfalen Germany 40225
38 GSK Investigational Site Essen Nordrhein-Westfalen Germany 45136
39 GSK Investigational Site Herne Nordrhein-Westfalen Germany 44625
40 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 51067
41 GSK Investigational Site Mainz Rheinland-Pfalz Germany 55131
42 GSK Investigational Site Halle Sachsen-Anhalt Germany 06120
43 GSK Investigational Site Magdeburg Sachsen-Anhalt Germany 39104
44 GSK Investigational Site Bad Berka Thueringen Germany 99437
45 GSK Investigational Site Berlin Germany 13353
46 GSK Investigational Site Berlin Germany 14165
47 GSK Investigational Site Bremen Germany 28177
48 GSK Investigational Site Hamburg Germany 20246
49 GSK Investigational Site Hamburg Germany 22081
50 GSK Investigational Site Budapest Hungary 1106
51 GSK Investigational Site Budapest Hungary 1125
52 GSK Investigational Site Budapest Hungary 1529
53 GSK Investigational Site Győr Hungary 9024
54 GSK Investigational Site Törökbálint Hungary 2045
55 GSK Investigational Site Chieti Scalo Abruzzo Italy 66013
56 GSK Investigational Site Genova Liguria Italy 16128
57 GSK Investigational Site Bergamo Lombardia Italy 24128
58 GSK Investigational Site Milano Lombardia Italy 20142
59 GSK Investigational Site Milano Lombardia Italy 20153
60 GSK Investigational Site Pavia Lombardia Italy 27100
61 GSK Investigational Site Campobasso Molise Italy 86100
62 GSK Investigational Site Firenze Toscana Italy 50139
63 GSK Investigational Site Padova Veneto Italy 35128
64 GSK Investigational Site Almelo Netherlands 7609 PP
65 GSK Investigational Site Amsterdam Netherlands 1061 AE
66 GSK Investigational Site Amsterdam Netherlands 1066 EC
67 GSK Investigational Site Amsterdam Netherlands 1105 AZ
68 GSK Investigational Site Breda Netherlands 4818 CK
69 GSK Investigational Site Delft Netherlands 2625 AD
70 GSK Investigational Site Den Haag Netherlands 2545 CH
71 GSK Investigational Site Eindhoven Netherlands 5631 BM
72 GSK Investigational Site Enschede Netherlands 7511JX
73 GSK Investigational Site Nieuwegein Netherlands 3435 CM
74 GSK Investigational Site Nijmegen Netherlands 6532 SZ
75 GSK Investigational Site Rotterdam Netherlands 3078 HT
76 GSK Investigational Site Sittard Netherlands 6131 BK
77 GSK Investigational Site Winterswijk Netherlands 7101 BN
78 GSK Investigational Site Zwolle Netherlands 8025 AB
79 GSK Investigational Site Bialystok Poland 15-027
80 GSK Investigational Site Krakow Poland 31-115
81 GSK Investigational Site Lubin Poland 59-301
82 GSK Investigational Site Olsztyn Poland 10-228
83 GSK Investigational Site Olsztyn Poland 10-699
84 GSK Investigational Site Warszawa Poland 00-909
85 GSK Investigational Site Arkhangelsk Russian Federation 163045
86 GSK Investigational Site Kazan Russian Federation 420111
87 GSK Investigational Site Kirov Russian Federation 610021
88 GSK Investigational Site Moscow Russian Federation 107005
89 GSK Investigational Site Omsk Russian Federation 644013
90 GSK Investigational Site Orenburg Russian Federation 460021
91 GSK Investigational Site Samara Russian Federation 443066
92 GSK Investigational Site St. Petersburg Russian Federation 191104
93 GSK Investigational Site Voronezh Russian Federation 394062
94 GSK Investigational Site Golnik Slovenia 4204
95 GSK Investigational Site Ljubljana Slovenia 1000

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00312013
Other Study ID Numbers:
  • FRX106365
First Posted:
Apr 7, 2006
Last Update Posted:
Mar 23, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
low molecular weight heparin
nadroparin
non-small cell lung cancer
cancer survival
prostate cancer
pancreatic cancer
Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Nadroparin

Study Results

No Results Posted as of Mar 23, 2017