A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)
This study is currently recruiting participants.
Verified February 2013 by University of Rochester
Sponsor:
University of Rochester
Collaborators:
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester
ClinicalTrials.gov Identifier:
NCT00876915
First received: March 31, 2009
Last updated: February 20, 2013
Last verified: February 2013
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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: | September 2013 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876915
Contacts
| Contact: Charles Francis, MD | 585-275-3761 | Charles_Francis@URMC.Rochester.edu |
Locations
| United States, California | |
| University of California, Davis | Not yet recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Ted Wun, M.D., FACP 916-734-3772 | |
| Sub-Investigator: Ted Wun, MD, FACP | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Renuka Iyer, MD 716-845-3099 | |
| Sub-Investigator: Renuka Iyer, MD | |
| Rochester General Hospital | Recruiting |
| Rochester, New York, United States, 14621 | |
| Contact: Mehul Patel, MD 585-922-4020 | |
| Sub-Investigator: Mehul Patel, MD | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Charles W. Francis, MD 585-275-3761 Charles_Francis@URMC.Rochester.edu | |
| Principal Investigator: Charles W. Francis, MD | |
| Sub-Investigator: Alok A. Khorana, MD | |
| United States, North Carolina | |
| Duke University School of Medicine | Recruiting |
| Durham, North Carolina, United States, 27705 | |
| Contact: Gary Lyman, MD 919-681-1604 Gary.Lyman@Duke.Edu | |
| Principal Investigator: Gary Lyman, MD, MPH | |
| Canada, Ontario | |
| Ottawa Hospital Research Institute (OHRI) | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Marc Carrier, MD, MSc 613-737-8899 | |
| Sub-Investigator: Marc Carrier, MD, MSc | |
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: | February 20, 2013 |
| 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:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Thrombosis Embolism Pulmonary Embolism Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
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 June 17, 2013