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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00312013

Enrollment

503

Registered

2006-04-07

Start date

2006-05-31

Completion date

2009-07-31

Last updated

2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis, Venous

Keywords

low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer

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).

Interventions

DRUGNadroparin

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
Time to tumor progression	46 weeks

Countries

Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026