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| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006083 |
Purpose
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.
| Condition | Intervention | Phase |
|
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: dalteparin |
Phase III |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Cervical Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| 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 |
| Study Start Date: | January 2000 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: 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
PATIENT CHARACTERISTICS: Age: 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: No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure No myocardial infarction in past 6 months No uncontrolled cardiac arrhythmia Other: No known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins No active uncontrolled infection, including existing catheter related infection HIV negative No CNS trauma in past 3 months No retinal detachment in past 6 months No mental incapacitation or psychiatric illness that would preclude study compliance No other serious concurrent disease that would preclude study participation No active gastrointestinal or genitourinary tract bleeding No intracranial or intraocular hemorrhage in past year Must weigh at least 90 pounds
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent high dose chemotherapy with stem cell transplantation Chemotherapy: See Disease Characteristics No concurrent induction/consolidation chemotherapy for leukemia No concurrent high dose chemotherapy with stem cell transplantation Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: 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)
Contacts and Locations| United States, California | |||||
| Jonsson Comprehensive Cancer Center, UCLA | |||||
| Los Angeles, California, United States, 90095-1781 | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068075, UCLA-9910055, P-UPJOHN-98-FRAG-076, NCI-G00-1822 |
| First Received: | August 3, 2000 |
| Last Updated: | August 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006083 |
| Health Authority: | United States: Federal Government |
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