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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006083
• Other study ID #: CDR0000068075
• Secondary ID: UCLA-9910055P-UP
• Status: Completed
• Phase: Phase 3
• Start date: April 2000
• Est. completion date: November 2000

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2000
• Est. primary completion date: November 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Precancerous Conditions
• Precancerous/Nonmalignant Condition
• Preleukemia
• Syndrome
• Unspecified Adult Solid Tumor, Protocol Specific
• Uterine Cervical Neoplasms
• Veno-occlusive Disease

Intervention

Drug:
• Fragmin
Fragmin at 5000 IU injected subcutaneously daily

Other:
• placebo
placebo injected subcutaneously daily

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Upjohn

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		16 weeks