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Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma

NCT00023998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-02-04

No results posted yet for this study

Summary

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of chemotherapy with or without trastuzumab in treating patients who have metastatic osteosarcoma

Conditions

  • Metastatic Osteosarcoma

Interventions

DRUG

doxorubicin hydrochloride

Given IV

DRUG

cisplatin

Given IV

DRUG

methotrexate

Given IV

DRUG

leucovorin calcium

Given IV or orally

BIOLOGICAL

filgrastim

Given IV

PROCEDURE

therapeutic conventional surgery

Undergo resection

RADIATION

radiation therapy

Undergo radiotherapy

DRUG

etoposide

Given IV

DRUG

ifosfamide

Given IV

BIOLOGICAL

trastuzumab

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • David Ebb · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2005-11-30
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00023998 on ClinicalTrials.gov