Trials / Completed
CompletedNCT00006083
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Jonsson Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- 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
| Type | Name | Description |
|---|---|---|
| DRUG | Fragmin | Fragmin at 5000 IU injected subcutaneously daily |
| OTHER | placebo | placebo injected subcutaneously daily |
Timeline
- Start date
- 2000-04-01
- Primary completion
- 2000-11-01
- Completion
- 2000-11-01
- First posted
- 2004-05-26
- Last updated
- 2020-08-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00006083. Inclusion in this directory is not an endorsement.