DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: 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

Intervention: Fragmin (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Jonsson Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
John A. Glaspy, MD, MPH, Study Chair, Affiliation: Jonsson Comprehensive Cancer Center

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Primary outcome: 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2000
Last updated: July 27, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017