Dalteparin to Prevent Complications in Cancer Patients Re... | NCT00006083 | Trialant
NCT00006083
Sponsor
Jonsson Comprehensive Cancer Center
Status
Completed
Last Update Posted
Aug 3, 2020Actual
Enrollment
Not provided
Phase
Phase 3
Conditions
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
Interventions
Fragmin
placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00006083
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000068075
Secondary IDs
ID
Type
Description
Link
UCLA-9910055
P-UPJOHN-98-FRAG-076
NCI-G00-1822
Brief Title
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
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
Acronym
Not provided
Organization
Jonsson Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Jul 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2000
Primary Completion Date
Nov 2000Actual
Completion Date
Nov 2000Actual
First Submitted Date
Aug 3, 2000
First Submission Date that Met QC Criteria
May 25, 2004
First Posted Date
May 26, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 30, 2020
Last Update Posted Date
Aug 3, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Jonsson Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
Upjohn
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Conditions Module
Conditions
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
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fragmin
Experimental
Fragmin at 5000 IU injected subcutaneously daily
Drug: Fragmin
placebo
Placebo Comparator
placebo injected subcutaneously daily
Other: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fragmin
Drug
Fragmin at 5000 IU injected subcutaneously daily
Fragmin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
16 weeks
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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