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Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006083
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Upjohn
Information provided by:
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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: Fragmin Other: placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
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
Study Start Date : April 2000
Actual Primary Completion Date : November 2000
Actual Study Completion Date : November 2000

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Multiple Myeloma Lymphosarcoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Follicular Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Marginal Zone Lymphoma Chronic Myeloproliferative Disorders Primary Central Nervous System Lymphoma Myelodysplastic Syndromes Cutaneous T-cell Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Chronic Lymphocytic Leukemia AL Amyloidosis Mantle Cell Lymphoma Peripheral T-cell Lymphoma Hodgkin Lymphoma Acute Graft Versus Host Disease Anaplastic Large Cell Lymphoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Primary Myelofibrosis Burkitt Lymphoma Chronic Graft Versus Host Disease Monoclonal Gammopathy of Undetermined Significance Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Hairy Cell Leukemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia Adult T-cell Leukemia/lymphoma Essential Thrombocythemia Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Plasmacytoma Leukemia, T-cell, Chronic

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fragmin
Fragmin at 5000 IU injected subcutaneously daily
 Drug: Fragmin
Fragmin at 5000 IU injected subcutaneously daily
Placebo Comparator: placebo
placebo injected subcutaneously daily
 Other: placebo
placebo injected subcutaneously daily


Outcome Measures
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Primary Outcome Measures :
  1. To determine if 5000 IU of Fragmin administered daily when compared to placebo will reduce the incidence of clinically relevant CRCs in cancer patients receiving chemotherapy by CVC [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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:
  • HIV negative
  • Must weigh at least 90 pounds
  • 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)

Exclusion Criteria:

  • uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
  • myocardial infarction in past 6 months
  • uncontrolled cardiac arrhythmia Other:
  • known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins
  • active uncontrolled infection, including existing catheter related infection
  • CNS trauma in past 3 months
  • retinal detachment in past 6 months
  • mental incapacitation or psychiatric illness that would preclude study compliance
  • other serious concurrent disease that would preclude study participation
  • active gastrointestinal or genitourinary tract bleeding
  • intracranial or intraocular hemorrhage in past year
  • concurrent high dose chemotherapy with stem cell transplantation
  • concurrent induction/consolidation chemotherapy for leukemia
  • concurrent high dose chemotherapy with stem cell transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006083


Locations
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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Upjohn
Investigators
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Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
More Information
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Responsible Party: John Glaspy, Jonsson Comprehensive Cancer center
ClinicalTrials.gov Identifier: NCT00006083    
Other Study ID Numbers: CDR0000068075
UCLA-9910055
P-UPJOHN-98-FRAG-076
NCI-G00-1822
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2012
Keywords provided by Jonsson Comprehensive Cancer Center:
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:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Uterine Cervical Neoplasms
Plasmacytoma
Precancerous Conditions
Myelodysplastic Syndromes
Myeloproliferative Disorders
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms