NeoplasmsPhase 2NCT00041782
Outpatient Treatment Of Deep Venous Thrombosis Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients
A Phase 2 study testing Dalteparin (Fragmin) in people with Neoplasms and Deep Vein Thrombosis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Deep Vein Thrombosis
- What is being tested?
- Dalteparin (Fragmin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jan 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- Patients with adequate bone marrow function: platelets >100,000/mm3, and ANC >1,500 cells/mm3.
- 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 visits.
- Patients must be able to read to complete study instruments.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients
Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed on injection technique, will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary. Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin, routine lab work and initiation of oral anticoagulation therapy.
Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator. On days of home injection, the study nurse will call the patient to check on the patient's status and to remind the patient of his/her daily injection. Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition warrants modification of therapy with or without hospitalization. Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.
The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis. Patients will complete these two instruments at study entry, day 3, day 5 and at the end of study if different from day 5.
- Conditions
- Neoplasms, Deep Vein Thrombosis
- Being tested
- Dalteparin (Fragmin)
- Keywords
- Deep Vein Thrombosis
- Medical subject headings
- Neoplasms, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin (Fragmin)Drug
200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU).
| Study group | Role | What they receive |
|---|---|---|
| Dalteparin | Experimental | Not described Receives: Drug: Dalteparin (Fragmin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Survey Responses
Measured: Collection over study period (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2002 (estimated)
- Study startOct 2000
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brookdale University Hospital Medical Center, Josephine Ford Cancer Center
- Responsible party
- Sponsor
- Investigators
- Carmelita P. Escalante, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041782
- Sponsor's protocol ID
- ID00-078
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients
- ClinicalTrials.gov ID
- NCT00041782
- Acronym / sponsor ID
- ID00-078
- Conditions
- Neoplasms, Deep Vein Thrombosis
- Keywords
- Deep Vein Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Brookdale University Hospital Medical Center, Josephine Ford Cancer Center
- Study start
- Oct 2000 (actual)
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 19 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed on injection technique, will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary. Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin, routine lab work and initiation of oral anticoagulation therapy.
Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator. On days of home injection, the study nurse will call the patient to check on the patient's status and to remind the patient of his/her daily injection. Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition warrants modification of therapy with or without hospitalization. Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.
The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis. Patients will complete these two instruments at study entry, day 3, day 5 and at the end of study if different from day 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dalteparin | Experimental | Drug: Dalteparin (Fragmin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Cancer patients with documented DVT and meeting eligibility criteria will be entered on the study if they consent to participate.
- 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)
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalteparin (Fragmin)200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). | Drug | Dalteparin |
Primary outcome
Quality of Life Survey Responses
Time frame: Collection over study period (5 years)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelita P. Escalante, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalteparin (Fragmin) in people with Neoplasms and Deep Vein Thrombosis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Survey Responses (time frame: Collection over study period (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.