A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
- Conditions
- Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 14.1Level: LLTClassification code 10065868Term: Embryonal rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061526Term: Malignant mesenchymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10058387Term: Schwannoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039024Term: Rhabdomyosarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039026Term: Rhabdomyosarcoma previously untreatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10024189Term: LeiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2007-005017-19-Outside-EU/EEA
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 150
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- previous malignant tumors
- tumor invading major blood vessels
- prior systemic anti-tumor treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in childhood and adolescent patients presenting with metastatic RMS and NRSTS as assessed by Event-Free Survival (EFS).<br>;Secondary Objective: 1. To determine the safety, tolerability and efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in patients presenting with metastatic RMS and NRSTS, as assessed by:<br>• Adverse event profile.<br>• Discontinuation or modification or delay of any treatment element<br>• Overall response rate (according to RECIST v1.0) prior to local therapy.<br>• Overall survival (OS).<br>• Duration of response (DR)<br>2. To characterize the pharmacokinetic (PK) profile of bevacizumab across all age subsets of the study population.<br>;Primary end point(s): Event-free survival;Timepoint(s) of evaluation of this end point: 19 months after last patient randomized
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - AEs, lab parameters<br>- Overall response rate, duration of response, overall survival of response<br>- Pharmacokinetic profile;Timepoint(s) of evaluation of this end point: For AEs, throughout study every 3-4 weeks<br>For ORR, duration of response and OS 19 months after last patient randomized<br>For PK profile, sampling on experimental arm on first 4 cycles of induction therapy only