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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 3

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Unspecified Adult Solid Tumor, Protocol Specific

Chronic Myeloproliferative Disorders

Precancerous/Nonmalignant Condition

Lymphoma

Leukemia

Myelodysplastic Syndromes

Cervical Cancer

Veno-occlusive Disease

Treatments

Other: placebo

Drug: Fragmin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00006083

CDR0000068075

P-UPJOHN-98-FRAG-076

NCI-G00-1822

UCLA-9910055

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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