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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00312013
First received: April 5, 2006
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Thrombosis, Venous
Drug: Nadroparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The INPACT Study (Improving With Nadroparin the Prognosis in Advanced Cancer Treatment). 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • Time to tumor progression [ Time Frame: 46 weeks ]

Enrollment: 503
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 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
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.
Other Name: Nadroparin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312013

  Show 83 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00312013     History of Changes
Other Study ID Numbers: FRX106365
Study First Received: April 5, 2006
Last Updated: May 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by GlaxoSmithKline:
low molecular weight heparin
nadroparin
non-small cell lung cancer
cancer survival
prostate cancer
pancreatic cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Thrombosis
Venous Thrombosis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Nadroparin
Pancrelipase
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 29, 2014