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

Study Overview

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).

N/A

Thrombosis, Venous

DRUG: Nadroparin

FRX106365

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-04-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-21
First Submitted that Met QC Criteria 2006-04-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-23
First Posted (ACTUAL) 2006-04-07	Results First Posted N/A	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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, subse	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

Participant Group/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, subse

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

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
Time to tumor progression		46 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: GSK Clinical Trials, GlaxoSmithKline

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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