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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006083
First received: August 3, 2000
Last updated: July 27, 2012
Last verified: July 2012

August 3, 2000
July 27, 2012
April 2000
November 2000   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00006083 on ClinicalTrials.gov Archive Site
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Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
  • 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
    Fragmin at 5000 IU injected subcutaneously daily
  • Other: placebo
    placebo injected subcutaneously daily
  • Experimental: Fragmin
    Fragmin at 5000 IU injected subcutaneously daily
    Intervention: Drug: Fragmin
  • Placebo Comparator: placebo
    placebo injected subcutaneously daily
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2000
November 2000   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006083
CDR0000068075, P30CA016042, UCLA-9910055, P-UPJOHN-98-FRAG-076, NCI-G00-1822
Yes
John Glaspy, Jonsson Comprehensive Cancer center
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP