Phase 2
N=43
A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
Osteosarcoma · Malignant Fibrous Histiocytoma (MFH) of Bone
Bottom Line
View on ClinicalTrials.gov: NCT00667342 ↗Enrolled (actual)
43
Serious AEs
7.1%
Results posted
Aug 2014
Primary outcome: Primary: Number of Participants With Unacceptable Toxicity — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological); Cisplatin (Drug); Doxorubicin (Drug); Methotrexate (Drug); Ifosfamide (Drug); etoposide (Drug); Surgery (Procedure); Radiotherapy (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unacceptable Toxicity |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 3-Year Event Free Survival |
0.575 | — |
| SECONDARY Histologic Response by Stratum |
1; 0; 5; 1; 17; 7 | — |
| SECONDARY 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma |
0.617 | — |
| SECONDARY 2-Year Overall Survival (OS) of Patients With Osteosarcoma |
0.880 | — |
| SECONDARY 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. |
0.642 | — |
| SECONDARY 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. |
0.934 | — |
| SECONDARY Mean Ktrans |
0.13; 0.15; 0.11; 0.14; 0.12; 0.16 | 0.0863 |
| SECONDARY Mean Vp |
0.0081; 0.0094; 0.0067; 0.0077; 0.0070; 0.0095 | 0.0573 |
| SECONDARY Mean Ve |
0.2543; 0.2671; 0.2444; 0.2623; 0.2564; 0.2602 | 0.0863 |
| SECONDARY Histologic Response by Number of Participants |
22; 18 | — |
| SECONDARY Ktrans by Good and Poor Response |
0.0775; 0.0491 | — |
| SECONDARY P95 of Ktrans by Good and Poor Response |
0.2047; 0.1228 | — |
| SECONDARY Difference Between Good and Poor Response by SUVmax |
6.2894; 3.2720 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00667342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.