Trial information

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

Status: Recruiting

Protocol number: BO20924

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: An open-label, randomized, two stage adaptive design study of the safety and effect on event-free survival of Avastin in combination with standard chemotherapy in minor patients with metastatic rhabdomyosarcoma, non-rhabdomyosarcoma soft-tissue sarcoma or Ewing’s sarcoma/soft-tissue primitive neuro

Brief summary: This study will assess the safety and efficacy of a combination of Avastin and standard chemotherapy, compared with standard chemotherapy alone, in childhood and adolescent patients with metastatic rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) or Ewing's sarcoma/soft tissue primitive neuroectodermal tumors (ET/PNET). Patients will be randomized to receive Avastin + standard chemotherapy or standard chemotherapy alone.Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy, +/- Avastin 7.5mg iv on day 1 of each cycle) followed by 4-week cycles of maintenance treatment (standard chemotherapy, +/- Avastin 5mg/kg iv on days 1 and 15 of each cycle). A safety analysis will be carried out after the first 44 patients have completed 6 cycles of treatment, before further patients are recruited. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 45.

Study phase: II

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Sarcoma

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: 1. Part 1 (first 44 patients): Incidence rate of patients with dose discontinuation or dose modification/delay of study treatment Time frame: After 6 cycles of treatment 2. Part 2 (whole study population): Event-free survival Time frame: Event-driven

Key secondary outcomes: 1. Part 2 only: Overall response, duration of response, overall survival Time frame: Event-driven 2. AEs, lab parameters Time frame: Throughout study

Inclusion criteria:

• childhood and adolescent patients aged 2-17 years (potentially extended to 6 months for RMS if there is an acceptable safety profile for the first 44 patients);
• newly diagnosed, untreated metastatic RMS, NRSTS and ET/PNET;
• adequate cardiac function;
• no increased risk of gastrointestinal, cardiovascular, renal, bleeding disorders or wound-healing complications.

Exclusion criteria:

• previous malignant tumors;
• tumor invading major blood vessels;
• prior systemic anti-tumor treatment.

Gender: Males or Females

Age limits: Min: 2 Years Max: 17 Years

Accepts healthy volunteers: No

Anticipated start date: July, 2008

Trial registration date: 03/18/2008

Date last updated: 8/19/2008

Link to trial result

This trial is being conducted at the following locations:

France

• Lille
• Lyon
• Marseille
• Nantes
• Paris
• Toulouse
• Villejuif

Italy

• Genova
• Milano
• Padova

Netherlands

• Amsterdam
• Rotterdam

United Kingdom

• Birmingham
• Bristol
• Glasgow
• Leeds
• London
• Manchester
• Newcastle upon Tyne
• Surrey