A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
Summary
This open-label two-arm study will assess the safety and efficacy of a combination of
bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in
childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma
soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard
chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of
induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1
of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy
with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time
on study treatment is 1-2 years.