Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 3, 2002

Last Updated Date

August 20, 2009

Start Date ^ICMJE

April 2000

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Duration of severe neutropenia in chemotherapy cycles 1 and 3
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3

Change History

Complete list of historical versions of study NCT00035620 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
Overall rates of febrile neutropenia [ Time Frame: all cycles ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetic profile in chemotherapy cycles 1 and 3
Incidence of adverse events across all cycles of chemotherapy
Overall rates of febrile neutropenia

Descriptive Information

Brief Title ^ICMJE

Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy

Official Title ^ICMJE

A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

Brief Summary

Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sarcoma
Neutropenia

Intervention ^ICMJE

Drug: pegfilgrastim
Drug: filgrastim

Study Arms / Comparison Groups

Active Comparator: Filgrastim
Experimental: Pegfilgrastim

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia

Administrative Information

NCT ID ^ICMJE

NCT00035620

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

990130

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP