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

Phase 3CompletedNCT00312013

GlaxoSmithKline503 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

503

Conditions

Thrombosis, Venous

Interventions

NadroparinDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (95)

Outcomes

Primary Outcomes

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 Outcomes

Time to tumor progression

Time frame: 46 weeks

Data from ClinicalTrials.gov

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GSK Investigational Site

Aalst, Belgium

GSK Investigational Site

Antwerp, Belgium

GSK Investigational Site

Brasschaat, Belgium

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Brussels, Belgium

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Brussels, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Toronto, Ontario, Canada

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Brno, Czechia

GSK Investigational Site

Prague, Czechia

...and 85 more locations