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
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
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
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, UCLA | Los Angeles, California 90095-1781 |
