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Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients

Phase 2
18 Years
Not Enrolling
Neoplasms, Deep Vein Thrombosis

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Trial Information

Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients

Inclusion Criteria

Inclusion Criteria

Cancer patients with documented DVT and meeting eligibility criteria will be entered on
the study if they consent to participate.

Patients eligible for the study will include:

- Patients with solid tumors (including lymphoma and myeloma).

- Patients with clinical and venographic or ultrasonographic evidence of thrombosis of
the proximal or distal lower or upper extremity.

- Patients with catheter-related thrombosis will be eligible for the study if they are
not candidates for thrombolytic therapy.

- Patients with Zubrod performance status of <2. (Appendix A)

- Patients with adequate bone marrow function: platelets >100,000/mm3, and ANC >1,500

- Patients with adequate renal function: creatinine < 2.5 mg/dL.

- Patients with adequate liver function: SGPT < 1.5 x upper limit of normal, alkaline
phosphatase < 2.5 x upper limit of normal, bilirubin < 1.5 mg/dL.

- Patients must have caregiver available and willing to assist with care and
transportation for the first 72 hours of the study period.

- Patients must have a telephone within the home.

- Patients must live or stay within a 30-mile radius of the study site.

- Patients must have a history of compliance with outpatient therapy and follow-up

- Patients must be able to read to complete study instruments.

Exclusion Criteria

A patient must not be enrolled if any of these criteria apply:

- Prior history of DVT or PE in the past year.

- Evidence of active bleeding, active peptic ulcer disease, or a familial bleeding
disorder proven with a diagnostic study.

- A Hemoglobin of 7.5 or less.

- Concurrent symptomatic PE in the past year.

- Currently receiving treatment with UFH for DVT.

- An inability to be treated with LMWH as an outpatient because of comorbidities or
clinical condition requiring hospitalization: (cerebral vascular accident,
uncontrolled diabetes mellitus, uncontrolled hypertension, new onset atrial
fibrillation, chronic obstructive pulmonary disease with dyspnea, and / or trauma).

- Hypotension (systolic blood pressure < 90 mm Hg).

- Tachypnea (respiratory rate > 30/min.).

- Altered sensorium.

- Uncontrolled hypercalcemia (Corrected calcium > 12mg/dL).

- Hyponatremia (serum sodium < 128 mg/dL).

- Women who are pregnant or nursing.

- Expected decrease in the platelet count of less than 50,000 during the next 10 days
following entry.

- Patients with the presence of known deficiency of antithrombin III, protein C, or
protein S.

- Patients with known history of activated protein C resistance.

- Patients on oral anticoagulants (anisindione, dicumarol or warfarin) and/or platelet
inhibitors (aspirin, abciximab, alprostadil, dipyridamole, sulfinpyrazone,
ticlopidine or NSAIDS) that could affect hemostasis.

- Patients with previous heparin-induced thrombocytopenia.

- Patients with epidural catheters.

- Patients with a hypersensitivity reaction of UFH, dalteparin or porcine products.

- Patients with known non-compliance with previous treatment regimens.

- Patients with primary central nervous system tumors, brain metastases or evidence of
leptomeningeal disease.

- Treatment Plan (Appendix B)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of Life Survey Responses

Outcome Time Frame:

Collection over study period (5 years)

Safety Issue:


Principal Investigator

Carmelita P. Escalante, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2000

Completion Date:

January 2005

Related Keywords:

  • Neoplasms
  • Deep Vein Thrombosis
  • Deep Vein Thrombosis
  • Neoplasms
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism



UT MD Anderson Cancer Center Houston, Texas  77030