LymphomaNCT00004875
Heparin or Enoxaparin in Patients With Cancer
An observational study of Lymphoma and Thromboembolism, run by Northwestern University at 2 sites in United States.
Trial summary
RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor. PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- enoxaparin and heparin
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1996to Mar 1999
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A group of cancer patients representing a large variety of different tumor types will be observed after receiving standard heparin or enoxaprin to determine risk for thromboembolic disease.
DISEASE CHARACTERISTICS: Histologically proven malignancy, including lymphomas No leukemias
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 6 months Hematopoietic: Hemoglobin greater than 8.5 g/dL Platelet count greater than 100,000/mm3 No history of heparin and/or low weight molecular heparin induced thrombocytopenia No history of bleeding diathesis Hepatic: No history of coagulation factor deficiency No hepatic encephalopathy No hepatic failure No cirrhosis No hemophilia Renal: Creatinine less than 2.5 mg/dL (no greater than upper limit of normal for diabetes mellitus) Cardiovascular: No New York Heart Association class III or IV heart disease No congestive heart failure No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mmHg and diastolic blood pressure at least 110 mmHg) No endocarditis No hemorrhagic stroke No prior or concurrent deep vein thrombosis Pulmonary: No prior or concurrent pulmonary embolus Other: No known allergy to enoxaparin or standard heparin No known allergy to fish (e.g., protamine sulfate) or swine products No active ulcerative disease or angiodysplasia of the gastrointestinal (GI) tract or active GI bleeding within the past 6 months No other active significant medical illness or major failure of any organ system No refusal of donor blood products secondary to religious or other reasons Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 1 month since prior eye, spinal cord, or CNS surgery Other: At least 1 day since prior heparin or enoxaparin At least 1 week since prior therapeutic coumadin (prior prophylactic coumadin allowed) No other concurrent anticoagulants
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
Evanston Northwestern Health Care
Evanston, Illinois, 60201
About this study
Official title: Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin
RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor.
PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer.
Read the detailed description
OBJECTIVES: I. Determine the patterns of tissue factor pathway inhibitor (TFPI) release according to tumor type and type of anticoagulation (heparin or enoxaparin) in patients with cancer. II. Determine the incidence of portacath clots and its correlation to TFPI releasability in this patient population. III. Compare these anticoagulation drugs in terms of releasability of TFPI in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy within the past 3 weeks (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive a single dose of standard heparin subcutaneously (SQ) followed by evaluation of tissue factor pathway inhibitor (TFPI) response at 5 and 10 minutes post injection. Arm II: Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I. Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 20-200 patients will be accrued for this study over 6 months.
- Being tested
- enoxaparin, heparin
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, unspecified adult solid tumor, protocol specific, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse large cell lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult Burkitt lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Thromboembolism, Hodgkin Disease, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enoxaparinDrug
heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard Heparin | Not described Receives: Drug: heparin | |
| Enoxaprin | Not described Receives: Drug: enoxaparin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study startJul 1996
- Primary completionMar 1999
- Study completionMar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Hau C. Kwaan, MD, Study chair, Veterans Affairs Medical Center - Lakeside Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004875
- Sponsor's protocol ID
- NU 96X2
- Other IDs
- NU-96X2, NCI-G00-1670
- Status last verified
- Feb 2011
- First submitted
- 7 Mar 2000
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin
- ClinicalTrials.gov ID
- NCT00004875
- Acronym / sponsor ID
- NU 96X2
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, unspecified adult solid tumor, protocol specific, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1996
- Primary completion
- Mar 1999 (actual)
- Study completion
- Mar 1999 (actual)
- First posted
- 26 Jul 2004 (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.
RATIONALE: Heparin or enoxaparin may be effective in preventing the formation of blood clots in patients with cancer who are undergoing surgery to remove the tumor.
PURPOSE: Randomized clinical trial to compare the effectiveness of heparin with that of enoxaparin in patients who have cancer.
Detailed description
OBJECTIVES: I. Determine the patterns of tissue factor pathway inhibitor (TFPI) release according to tumor type and type of anticoagulation (heparin or enoxaparin) in patients with cancer. II. Determine the incidence of portacath clots and its correlation to TFPI releasability in this patient population. III. Compare these anticoagulation drugs in terms of releasability of TFPI in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy within the past 3 weeks (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive a single dose of standard heparin subcutaneously (SQ) followed by evaluation of tissue factor pathway inhibitor (TFPI) response at 5 and 10 minutes post injection. Arm II: Patients receive a single dose of enoxaparin SQ followed by evaluation of TFPI response as in arm I. Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 20-200 patients will be accrued for this study over 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Heparin | – | Drug: heparin |
| Enoxaprin | – | Drug: enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A group of cancer patients representing a large variety of different tumor types will be observed after receiving standard heparin or enoxaprin to determine risk for thromboembolic disease.
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 |
|---|---|---|
| enoxaparin | Drug | Enoxaprin |
| heparin | Drug | Standard Heparin |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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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.
Hau C. Kwaan, MD study chair
Veterans Affairs Medical Center - Lakeside Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Thromboembolism, run by Northwestern University at 2 sites 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?
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: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Feb 2011.