Clinical trial · Interventional
A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
A Study of Bevacizumab, a Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF), in Combination With Chemotherapy for Treatment of Osteosarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Fibrous Histiocytoma (MFH) of Bone | Undifferentiated High Grade Pleomorphic Sarcoma of Bone | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Localized Resectable Disease (Stratum A)
- description
- Participants with localized resectable disease receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin, and doxorubicin, or methotrexate. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, or methotrexate.
- interventionNames
- Biological: Bevacizumab
- Drug: Cisplatin
- Drug: Doxorubicin
- Drug: Methotrexate
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- Metastatic Disease (Stratum B)
- description
- Participants with metastatic disease (Stratum B) receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have newly diagnosed high-grade, biopsy proven, osteosarcoma or malignant fibrous histiocytoma (MFH) of bone with no history of prior chemotherapy or radiation; * Participant is able to perform tasks and daily activities as defined in the study guidelines * Patient meets established guidelines for adequate function of the kidney, liver, heart and bone marrow * Participants meets other requirements defined in the eligibility portion of the study Exclusion Criteria: * recent major surgical procedure or injury * Known bleeding diathesis, platelet disorder or coagulopathy * Thrombosis * Cardiac disease or hypertension * Significant proteinuria * Central nervous system disease * Gastrointestinal perforation/abdominal fistula * Osteosarcoma or MFH of bone as second malignancy
References
Publications (1)
- DERIVEDTurner DC, Navid F, Daw NC, Mao S, Wu J, Santana VM, Neel M, Rao B, Willert JR, Loeb DM, Harstead KE, Throm SL, Freeman BB 3rd, Stewart CF. Population pharmacokinetics of bevacizumab in children with osteosarcoma: implications for dosing. Clin Cancer Res. 2014 May 15;20(10):2783-92. doi: 10.1158/1078-0432.CCR-13-2364. Epub 2014 Mar 17. PMID 24637635