A study to look at the effectiveness of chemotherapy plus bevacizumab compared with chemotherapy alone in children and adolescents with metastatic soft tissue sarcoma (STS) (BERNIE)

A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.

  • Cancer
Trial Status:

Completed

This trial runs in
Countries
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • United Kingdom
Trial Identifier:

NCT00643565 2007-005017-19 BO20924

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT00643565 , BO20924 , 2007-005017-19 Trial Identifier
      Standard chemotherapy, bevacizumab [Avastin] Treatments
      Sarcoma Condition
      Official Title

      An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

      Eligibility Criteria

      All Gender
      ≥6 Months & ≤ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • childhood and adolescent patients aged >/=6 months to 18 years of age
      • metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
      • adequate bone marrow function
      • adequate renal and liver function
      • adequate blood clotting
      Exclusion Criteria
      • previous malignant tumors
      • tumor invading major blood vessels
      • prior systemic anti-tumor treatment

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