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

NCT00643565

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Sarcoma

Interventions: Standard chemotherapy, bevacizumab [Avastin]

Countries: Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Israel

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.

Eligibility overview

Sex: ALL

Age: 6 Months to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (61)
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Barretos, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Sainte-Foy, Quebec, Canada
  • Santiago, Chile
  • Brno, Czechia
  • Prague, Czechia
  • Bordeaux, France
  • Lille, France
  • Lyon, France
  • Marseille, France
  • Nantes, France
  • Paris, France
  • Rennes, France
  • Toulouse, France
  • Vandœuvre-lès-Nancy, France
  • Villejuif, France
  • Essen, Germany
  • Freiburg im Breisgau, Germany
  • Münster, Germany
  • Beersheba, Israel
  • Haifa, Israel
  • Petah Tikva, Israel
  • + 31 more on CT.gov