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

Condition(s): Sarcoma
NCTId: NCT00643565

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


This open-label two-arm study will assess the safety and efficacy of a combinati on of bevacizumab + standard chemotherapy with standard chemotherapy alone as ac tive comparator in childhood and adolescent patients with metastatic rhabdomyosa rcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized t

o receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Tr eatment will consist of 9 x 3-week cycles of induction treatment (standard chemo therapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followe d 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 Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 6 Months 18 Years False

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

Interventions & Outcomes

Study Interventions & Types

Drug Intervention(s)

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
Standard chemotherapy - As prescribed

Study Outcomes

Primary Outcome(s)

Timeframe: up to approximately 67 months
Measure: 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)
Safety Issue? No

Secondary Outcome(s)

Measure: Duration of response
Timeframe: up to approximately 67 months
Safety Issue? No

Measure: Overall response rate (defined as confirmed complete response or partial response on completion of induction chemotherapy, assessed by RECIST criteria)
Timeframe: approximately 67 months
Safety Issue? No

Measure: Overall survival
Timeframe: up to 9.5 years
Safety Issue? No

Measure: Pharmacokinetics: Bevacizumab blood concentrations
Timeframe: Pre- and within 3 hours post-dose on Day 1 Cycles 1-4, additional sampling Days 8 and 15 Cycle 1
Safety Issue? No

Measure: Safety: Incidence of adverse events
Timeframe: 9.5 years
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Düsseldorf, 40225 Germany

Essen, 45122 Germany

Freiburg, 79106 Germany

Münster, 48149 Germany

Beer Sheva, 8410101 Israel

Haifa, 31096 Israel

Petach-Tikva, 49100 Israel

Tel Aviv, 64239 Israel

Roma, Lazio 00165 Italy

Genova, Liguria 16148 Italy

Milano, Lombardia 20133 Italy

Torino, Piemonte 10126 Italy

Firenze, Toscana 50132 Italy

Padova, Veneto 35128 Italy

Amsterdam, 1105 AZ Netherlands

Rotterdam, 3015 GJ Netherlands

Lublin, 20-093 Poland

Warsaw, 04-746 Poland

Moscow, 117198 Russian Federation

St. Petersburg, 197110 Russian Federation

Barakaldo, Vizcaya 48903 Spain

Barcelona, 08035 Spain

Madrid, 28009 Spain

Malaga, 29011 Spain

Sevilla, 41 41013 Spain

Valencia, 46014 Spain

Birmingham, B4 6NH United Kingdom

Bristol, BS2 8BJ United Kingdom

Edinburgh, EH91LF United Kingdom

Glasgow, G3 8SJ United Kingdom

Leeds, LS9 7TF United Kingdom

Liverpool, L12 2AP United Kingdom

Villejuif, 94805 France

Vandoeuvre Les Nancy, 54511 France

Toulouse, 31059 France

Rennes, 35203 France

Paris, 75231 France

Nantes, 44093 France

Marseille, 13385 France

Lyon, 69373 France

Lille, 59020 France

Bordeaux, 33076 France

Praha 5, 150 06 Czech Republic

Brno, 613 00 Czech Republic

Santiago, 7500539 Chile

Sainte-foy, Quebec G1V 4G2 Canada

Toronto, Ontario M5G 1X8 Canada

Sao Paulo, SP 08270-070 Brazil

Sao Paulo, SP 05410-030 Brazil

Sao Paulo, SP 04023-062 Brazil

Barretos, SP 14784-400 Brazil

Porto Alegre, RS 90430-090 Brazil

Rio de Janeiro, RJ 20560-120 Brazil

Gent, 9000 Belgium

Bruxelles, 1020 Belgium

Bruxelles, 1200 Belgium

London, WC1N 3JH United Kingdom

Manchester, M27 4HA United Kingdom

Newcastle Upon Tyne, NE1 4LP United Kingdom

Nottingham, NG7 2UH United Kingdom

Surrey, SM2 5PT United Kingdom

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Sarcoma

Related Intervention Keywords

Related Sarcoma Research

  1. 18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Scans in Assessing Oxygen in Tumor Tissue of Patients With Soft Tissue Sarcoma Undergoing Chemotherapy With or Without Radiation Therapy
  2. A Phase I Study of Pazopanib as a Single Agent for Children With Refractory Solid Tumors
  3. A Phase I Trial of T Cells Expressing an Anti-GD2 Chimeric Antigen Receptor in Children and Young Adults With Non-neuroblastoma, GD2+ Solid Tumors
  4. A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
  5. A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
  6. A Phase II Trial of Combined Hydroxychloroquine and Sirolimus in Drug Refractory Advanced Sarcoma
  7. A Pilot Study of Tumor Cell Vaccine for High-risk Solid Tumor Patients Following Stem Cell Transplantation
  8. A Prospective Randomized Trial of Pre-Operative IMRT+Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma
  9. A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment
  10. A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma