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Completed

NCT Number: NCT00006083

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

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.

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Key information

Conditions

Cervical Cancer Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Myeloproliferative Disorders DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Nutritional and Metabolic Diseases Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Precancerous/Nonmalignant Condition Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases Veno-occlusive Disease Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fragmin

Drug

Fragmin at 5000 IU injected subcutaneously daily

Placebo

Other

placebo injected subcutaneously daily

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Upjohn

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
May 26, 2004
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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