Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter (NCT00006083) | Clinical Trial Compass
CompletedPhase 3
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
United StatesStarted 2000-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 incapacitati…
What they're measuring
1
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