Trial Information

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

Status: Not yet 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 2 Years Max: 17 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2008

Trial Registration Date: 03/18/2008

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 5:00:32 PM