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

Study Overview
=================
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).

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

Conditions
-----------------
Thrombosis, Venous

Intervention / Treatment
-----------------
* Drug: Nadroparin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Nadroparin<br>Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin | |
| Experimental: Nadroparin<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression |  | 46 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer