CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 enrolled
Drug / intervention
Bevacizumab +7 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00667342
NCT00667342Phase 2Completed
CompareCT.gov

A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma

St. Jude Children's Research Hospital·interventional·Posted Apr 28, 2008·Updated Aug 7, 2023

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Cisplatin, and 6 other interventions for Osteosarcoma and Malignant Fibrous Histiocytoma (MFH) of Bone. Completed, enrolled 43 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma, Malignant Fibrous Histiocytoma (MFH) of Bone
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartJun 3, 2008
Primary CompletionAug 1, 2014
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.2 years ago

Interventions

Bevacizumabbiological

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

Cisplatindrug

Given IV.

Doxorubicindrug

Given IV.

Methotrexatedrug

Given IV.

Ifosfamidedrug

Given IV.

etoposidedrug

Given IV.

Surgeryprocedure

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

Radiotherapyradiation

Radiation therapy delivered for positive margins or intralesional resections.