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| Tracking Information | |||||
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| First Received Date ICMJE | August 3, 2000 | ||||
| Last Updated Date | May 9, 2009 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006083 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Randomized, Double-Blind, Placebo Control | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: dalteparin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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) |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006083 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068075, UCLA-9910055, P-UPJOHN-98-FRAG-076, NCI-G00-1822 | ||||
| Study Sponsor ICMJE | Jonsson Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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