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

Primary Purpose

Thrombosis, Venous

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nadroparin
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis, Venous focused on measuring low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Nadroparin

Nadroparin

Arm Description

Patients will receive all standard anticancer treatment. Patients in this arm will not receive 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.

Outcomes

Primary Outcome Measures

Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).

Secondary Outcome Measures

Time to tumor progression

Full Information

First Posted
April 5, 2006
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00312013
Brief Title
Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Venous
Keywords
low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
503 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Nadroparin
Arm Type
No Intervention
Arm Description
Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin
Arm Title
Nadroparin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nadroparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).
Time Frame
AT least 46 weeks after randomization
Secondary Outcome Measure Information:
Title
Time to tumor progression
Time Frame
46 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
GSK Investigational Site
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
612 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 08
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pribram
ZIP/Postal Code
261 95
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Bethune Cedex
ZIP/Postal Code
62408
Country
France
Facility Name
GSK Investigational Site
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
GSK Investigational Site
City
Lyon
ZIP/Postal Code
69275
Country
France
Facility Name
GSK Investigational Site
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
GSK Investigational Site
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
GSK Investigational Site
City
Saint-Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
GSK Investigational Site
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
GSK Investigational Site
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86150
Country
Germany
Facility Name
GSK Investigational Site
City
Ebensfeld
State/Province
Bayern
ZIP/Postal Code
96250
Country
Germany
Facility Name
GSK Investigational Site
City
Planegg
State/Province
Bayern
ZIP/Postal Code
82152
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36043
Country
Germany
Facility Name
GSK Investigational Site
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
GSK Investigational Site
City
Greifenstein
State/Province
Hessen
ZIP/Postal Code
35753
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
GSK Investigational Site
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44625
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51067
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39104
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Berka
State/Province
Thueringen
ZIP/Postal Code
99437
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
GSK Investigational Site
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
GSK Investigational Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
GSK Investigational Site
City
Chieti Scalo
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
Facility Name
GSK Investigational Site
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24128
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20153
Country
Italy
Facility Name
GSK Investigational Site
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
GSK Investigational Site
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86100
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
GSK Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
GSK Investigational Site
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Enschede
ZIP/Postal Code
7511JX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3078 HT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Sittard
ZIP/Postal Code
6131 BK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Winterswijk
ZIP/Postal Code
7101 BN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
GSK Investigational Site
City
Lubin
ZIP/Postal Code
59-301
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
GSK Investigational Site
City
Olsztyn
ZIP/Postal Code
10-699
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
GSK Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kazan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
107005
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443066
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Voronezh
ZIP/Postal Code
394062
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
Facility Name
GSK Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
21502549
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FRX106365
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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