Trial record 2 of 3 for:    rhabdomyosarcoma and bevacizumab

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00643565
First received: March 20, 2008
Last updated: April 2, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: Standard chemotherapy
Drug: bevacizumab [Avastin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to 9.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 9.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to approximately 67 months ] [ Designated as safety issue: No ]

Enrollment: 154
Study Start Date: July 2008
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Standard chemotherapy
As prescribed
Drug: 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: 2 Drug: Standard chemotherapy
As prescribed

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 61 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00643565     History of Changes
Other Study ID Numbers: BO20924, 2007-005017-19
Study First Received: March 20, 2008
Last Updated: April 2, 2015
Health Authority: France:AFSSAPS/DEMEB

Additional relevant MeSH terms:
Bevacizumab
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on April 30, 2015