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Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter Clinical research trials and Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter. Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter clinical trial. Subjects typically recieve the finest healthcare available for their Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter  Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
For Condition: Leukemia,Cervical Cancer,Multiple Myeloma,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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) --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; No other serious concurrent disease that would preclude study; No active gastrointestinal or genitourinary tract bleeding; No intracranial or intraocular hemorrhage in past year; Must weigh at least 90 pounds
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068075; P-UPJOHN-98-FRAG-076,UCLA-9910055,NCI-G00-1822
Study Start Date: October 2000
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006083
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Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
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