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A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

NCT00667342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-08-07

Study results available
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Summary

This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.

Conditions

Interventions

BIOLOGICAL

Bevacizumab

Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).

DRUG

Cisplatin

Given IV.

DRUG

Doxorubicin

Given IV.

DRUG

Methotrexate

Given IV.

DRUG

Ifosfamide

Given IV.

DRUG

etoposide

Given IV.

PROCEDURE

Surgery

Participants undergo definitive surgery and assessment of histologic response at week 10.

RADIATION

Radiotherapy

Radiation therapy delivered for positive margins or intralesional resections.

Sponsors & Collaborators

Principal Investigators

  • Michael Bishop, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-03
Primary Completion
2014-08-31
Completion
2017-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00667342 on ClinicalTrials.gov