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

• Status: Completed
• Trial end date: 2000-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Upjohn
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight

Criteria

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 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