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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00643565

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Drug: bevacizumab [Avastin] Drug: Standard chemotherapy	Phase II

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Part 2 (whole study population): Event-free survival [ Time Frame: Event-driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Part 2 only: Overall response, duration of response, overall survival [ Time Frame: Event-driven ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	87
Study Start Date:	July 2008
Estimated Study Completion Date:	May 2014

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 7.5mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5mg/kg iv on days 1 and 15 of each 4-week cycle Drug: Standard chemotherapy As prescribed
2: Active Comparator	Drug: Standard chemotherapy As prescribed

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

childhood and adolescent patients aged 2-17 years (potentially extended to 6 months for RMS if there is an acceptable safety profile for the first 44 patients);
newly diagnosed, untreated metastatic RMS, NRSTS and ET/PNET;
adequate cardiac function;
no increased risk of gastrointestinal, cardiovascular, renal, bleeding disorders or wound-healing complications.

Exclusion Criteria:

previous malignant tumors;
tumor invading major blood vessels;
prior systemic anti-tumor treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643565

Contacts

Contact: Please reference Study ID Number: BO20924	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
MARSEILLE, France, 13385
	Recruiting
LYON, France, 69373
	Recruiting
PARIS, France, 75249
	Recruiting
VILLEJUIF, France, 94805
	Recruiting
LILLE, France, 59020
	Recruiting
Nantes, France, 44035
	Recruiting
Toulouse, France, 31026
Italy
	Recruiting
Genova, Italy, 16148
	Recruiting
Padova, Italy, 35128
	Recruiting
MILANO, Italy, 20133
Netherlands
	Recruiting
AMSTERDAM, Netherlands, 1105 AZ
	Recruiting
Rotterdam, Netherlands, 3015 GJ
United Kingdom
	Not yet recruiting
BIRMINGHAM, United Kingdom, B4 6NH
	Recruiting
LONDON, United Kingdom, WC1N 3JH
	Recruiting
Manchester, United Kingdom, M27 4HA
	Recruiting
GLASGOW, United Kingdom, G3 8SJ
	Recruiting
NEWCASTLE UPON TYNE, United Kingdom, NE1 4LP
	Recruiting
Bristol, United Kingdom, BS2 8BJ
	Recruiting
LEEDS, United Kingdom, LS9 7TF
	Recruiting
SURREY, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO20924, 2007-005017-19
Study First Received:	March 20, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00643565 History of Changes
Health Authority:	France:AFSSAPS/DEMEB

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Sarcoma, Ewing's
Sarcoma

Bevacizumab
Ewing's Family of Tumors
Angiogenesis Inhibitors
Ewing's Sarcoma
Rhabdomyosarcoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009