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

Summary

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

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

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