A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester
ClinicalTrials.gov Identifier:
NCT00876915
First received: March 31, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.


Condition Intervention Phase
Venous Thromboembolism
Pulmonary Embolism
Drug: dalteparin injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective Randomized Multicenter Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To conduct a prospective, randomized clinical trial comparing the safety and efficacy of prophylaxis with dalteparin to no treatment in reducing VTE in high-risk ambulatory cancer patients initiating chemotherapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To establish the value of tissue factor (TF) as a predictive marker for VTE in ambulatory cancer patients receiving chemotherapy. [ Time Frame: baseline evaluation of tissue factor and then monthly for 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 229
Study Start Date: July 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dalteparin injection
Patients will be assigned at random to receive prophylactic dalteparin injections
Drug: dalteparin injection
Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).
Other Name: Fragmin
No Intervention: No therapy
No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A histologic diagnosis of malignancy;
  • At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);
  • A risk score for VTE ≥3 [assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites], hemoglobin <10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count > 11,000/mm3 or body mass index ≥ 35 kg/m2]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.
  • Age 18 years or older
  • Provide written, informed consent.

Exclusion Criteria:

  • Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator
  • Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome
  • Planned stem cell transplant
  • Life expectancy < 6 months
  • Known allergy to heparin or LMWH
  • Patient or caregiver incapable of daily self-injection
  • Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min
  • History of heparin-induced thrombocytopenia
  • Allergy to contrast agents
  • Pregnancy
  • Need for anticoagulant therapy
  • Platelet count < 75,000/mm3
  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: NCT00876915

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Rochester General Hospital
Rochester, New York, United States, 14621
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27705
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Canada, Ontario
Ottawa Hospital Research Institute (OHRI)
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
University of Rochester
Eisai Inc.
Investigators
Principal Investigator: Charles W. Francis, MD Univeristy of Rochester Medical Center
  More Information

No publications provided

Responsible Party: Charles Francis, Professor emeritus, University of Rochester
ClinicalTrials.gov Identifier: NCT00876915     History of Changes
Other Study ID Numbers: 25387, 1 R01 HL95109-01
Study First Received: March 31, 2009
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
prevention of VTE and PE in high risk cancer patients

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014