Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter

Completed · Phase 3 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00006083

Run by

Jonsson Comprehensive Cancer Center

Starts

2000-04-01

Expected to finish

2000-11-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 incapacitation or psychiatric illness that would preclude study compliance
• other serious concurrent disease that would preclude study participation
• active gastrointestinal or genitourinary tract bleeding
• intracranial or intraocular hemorrhage in past year
• concurrent high dose chemotherapy with stem cell transplantation
• concurrent induction/consolidation chemotherapy for leukemia
• concurrent high dose chemotherapy with stem cell transplantation

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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