A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
NCT ID: NCT00667342
Last Updated: 2023-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2008-06-03
2017-08-31
Brief Summary
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Detailed Description
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* To find out if bevacizumab can be combined safely with chemotherapy for osteosarcoma
* To find out if adding bevacizumab to chemotherapy will be beneficial in treating osteosarcoma.
The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. After completion of active therapy, patient's response to therapy will be followed for approximately 5 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Localized Resectable Disease (Stratum A)
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.
Bevacizumab
Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
Cisplatin
Given IV.
Doxorubicin
Given IV.
Methotrexate
Given IV.
Surgery
Participants undergo definitive surgery and assessment of histologic response at week 10.
Metastatic Disease (Stratum B)
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.
Bevacizumab
Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
Cisplatin
Given IV.
Doxorubicin
Given IV.
Methotrexate
Given IV.
Ifosfamide
Given IV.
etoposide
Given IV.
Surgery
Participants undergo definitive surgery and assessment of histologic response at week 10.
Radiotherapy
Radiation therapy delivered for positive margins or intralesional resections.
Unresectable Disease (Stratum C)
Participants with unresectable disease (Stratum C) receive treatment identical to Stratum B: 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.
Bevacizumab
Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
Cisplatin
Given IV.
Doxorubicin
Given IV.
Methotrexate
Given IV.
Ifosfamide
Given IV.
etoposide
Given IV.
Surgery
Participants undergo definitive surgery and assessment of histologic response at week 10.
Radiotherapy
Radiation therapy delivered for positive margins or intralesional resections.
Interventions
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Bevacizumab
Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
Cisplatin
Given IV.
Doxorubicin
Given IV.
Methotrexate
Given IV.
Ifosfamide
Given IV.
etoposide
Given IV.
Surgery
Participants undergo definitive surgery and assessment of histologic response at week 10.
Radiotherapy
Radiation therapy delivered for positive margins or intralesional resections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Michael Bishop, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Rady Children's Hospital and Health Center
San Diego, California, United States
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
NCI/NIH - Pediatric Oncology Branch
Bethesda, Maryland, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Turner 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.
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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GENENTECH PHARM
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00846
Identifier Type: REGISTRY
Identifier Source: secondary_id
OS2008
Identifier Type: -
Identifier Source: org_study_id
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