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Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
This study is ongoing, but not recruiting participants.
First Received: August 3, 2000   Last Updated: May 9, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006083
  Purpose

RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications.

PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.


Condition Intervention Phase
Cervical Cancer
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Precancerous/Nonmalignant Condition
Unspecified Adult Solid Tumor, Protocol Specific
Veno-Occlusive Disease
Drug: dalteparin
Phase III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title: A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
Detailed Description:

OBJECTIVES: I. Determine if dalteparin will reduce the incidence of clinically significant catheter related complications (i.e., asymptomatic catheter related thrombosis) in cancer patients receiving chemotherapy through a central venous catheter.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment center and catheter placement (proximal to axilla vs distal to axilla). Patients are randomized to one of two treatment arms. Arm I: Patients receive dalteparin subcutaneously (SC) daily. Arm II: Patients receive placebo SC daily. Treatment continues for 16 weeks or until catheter removal in the absence of unacceptable toxicity. Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 345 patients (230 in arm I and 115 in arm II) will be accrued for this study over 6 months.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically confirmed malignancy No more than 5 days since placement of central venous catheter for administration of chemotherapy Expected length of catheter use at least 16 weeks

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 16 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 No known coagulopathy Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) except in case of Gilbert's syndrome AST no greater than 3 times ULN (no greater than 5 times ULN in case of liver metastases) PT/PTT no greater than 1.5 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure No myocardial infarction in past 6 months No uncontrolled cardiac arrhythmia Other: No known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins No active uncontrolled infection, including existing catheter related infection HIV negative No CNS trauma in past 3 months No retinal detachment in past 6 months No mental incapacitation or psychiatric illness that would preclude study compliance No other serious concurrent disease that would preclude study participation No active gastrointestinal or genitourinary tract bleeding No intracranial or intraocular hemorrhage in past year Must weigh at least 90 pounds

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent high dose chemotherapy with stem cell transplantation Chemotherapy: See Disease Characteristics No concurrent induction/consolidation chemotherapy for leukemia No concurrent high dose chemotherapy with stem cell transplantation Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 3 months since prior eye, ear, or CNS surgery Other: At least 30 days since prior aspirin, dipyridamole, unfractionated heparin, other low molecular weight heparins, or other anticoagulation therapy (except heparin flushing)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006083

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068075, UCLA-9910055, P-UPJOHN-98-FRAG-076, NCI-G00-1822
Study First Received: August 3, 2000
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00006083     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage IB cervical cancer
Burkitt lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
stage 0 chronic lymphocytic leukemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Blood Protein Disorders
Hematologic Agents
Fibrinolytic Agents
Paraproteinemias
Hemostatic Disorders
Leukemia
Fibrin Modulating Agents
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Therapeutic Uses
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Anticoagulants
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Multiple Myeloma
Lymphatic Diseases

ClinicalTrials.gov processed this record on November 25, 2009