This trial is active, not recruiting.

Condition sarcoma
Treatments standard chemotherapy, bevacizumab [avastin]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date July 2008
End date May 2019
Trial size 154 participants
Trial identifier NCT00643565, 2007-005017-19, BO20924


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
standard chemotherapy
As prescribed
bevacizumab [avastin]
7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
(Active Comparator)
standard chemotherapy
As prescribed

Primary Outcomes

Event-free survival (defined as time between randomization and disease progression, recurrence, insufficient therapeutic response after 3 cycles of induction therapy, second primary cancer or death of any cause)
time frame: up to approximately 67 months

Secondary Outcomes

Overall response rate (defined as confirmed complete response or partial response on completion of induction chemotherapy, assessed by RECIST criteria)
time frame: approximately 67 months
Duration of response
time frame: up to approximately 67 months
Overall survival
time frame: up to 9.5 years
Safety: Incidence of adverse events
time frame: 9.5 years
Pharmacokinetics: Bevacizumab blood concentrations
time frame: Pre- and within 3 hours post-dose on Day 1 Cycles 1-4, additional sampling Days 8 and 15 Cycle 1

Eligibility Criteria

Male or female participants from 6 months up to 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.