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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


Phase 3
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

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

Outcome Time Frame:

16 weeks

Safety Issue:

Yes

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068075

NCT ID:

NCT00006083

Start Date:

April 2000

Completion Date:

November 2000

Related Keywords:

  • 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
  • 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
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • chronic idiopathic myelofibrosis
  • essential thrombocythemia
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • 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 lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • 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
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • primary central nervous system lymphoma
  • prolymphocytic leukemia
  • primary systemic amyloidosis
  • veno-occlusive disease
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781