Trial record 1 of 1 for:    nct00667342
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A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00667342
First received: April 24, 2008
Last updated: July 11, 2014
Last verified: June 2014
Results First Received: June 9, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Osteosarcoma
Malignant Fibrous Histiocytoma (MFH) of Bone
Interventions: Biological: Bevacizumab
Drug: Cisplatin
Drug: Doxorubicin
Drug: Methotrexate
Drug: Ifosfamide
Drug: etoposide
Procedure: Surgery
Radiation: Radiotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty-three participants were enrolled between June 2008 and May 2012: 34 at St. Jude Children's Research Hospital, 6 at Rady Children's Hospital San Diego, 2 at Johns Hopkins University Hospital, and 1 at M.D. Anderson in Houston

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants had newly diagnosed high-grade, biopsy-proven osteosarcoma, or malignant fibrous histiocytoma (MFH) of bone

Reporting Groups
  Description
A: Localized Resectable Disease Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
B: Localized Unresectable Disease Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
C: Metastatic Tumors Stratum C participants had metastatic tumors.

Participant Flow:   Overall Study
    A: Localized Resectable Disease     B: Localized Unresectable Disease     C: Metastatic Tumors  
STARTED     31     0     12  
COMPLETED     17     0     3  
NOT COMPLETED     14     0     9  
Protocol Violation                 1                 0                 0  
Withdrawal by Subject                 1                 0                 0  
Physician Decision                 3                 0                 0  
Relapse or tumor progression                 9                 0                 7  
Adverse Event                 0                 0                 1  
Ineligible                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants were eligible if they were ≤30 years of age on date of diagnostic biopsy confirmation of high-grade osteosarcoma or malignant fibrous histiocytoma (MFH) of bone. Participants had no previous chemotherapy or radiation therapy.

Reporting Groups
  Description
A: Localized Resectable Disease Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
B: Localized Unresectable Disease Participants with localized unresectable primary tumors were to participate in Stratum B. No participants were enrolled to this stratum.
C: Metastatic Tumors Stratum C participants had metastatic tumors.
Total Total of all reporting groups

Baseline Measures
    A: Localized Resectable Disease     B: Localized Unresectable Disease     C: Metastatic Tumors     Total  
Number of Participants  
[units: participants]
  31     0     12     43  
Age  
[units: years]
Mean ± Standard Deviation
  12.7  ± 3.5         13.3  ± 4.2     12.9  ± 3.6  
Age  
[units: years]
Median ( Full Range )
  12.0  
  ( 6.0 to 20.0 )  
   
   
  12.0  
  ( 8.0 to 20.0 )  
  12.0  
  ( 6.0 to 20.0 )  
Gender  
[units: participants]
       
Female     15         5     20  
Male     16         7     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Unacceptable Toxicity   [ Time Frame: After all patients have completed therapy, up to 1 year after last patient is enrolled ]

2.  Secondary:   Histologic Response by Stratum   [ Time Frame: After 6 cycles of chemotherapy, up to 1 year after the start of therapy ]

3.  Primary:   3-Year Event Free Survival Compared to Historical Controls on the Intergroup Study 0133   [ Time Frame: After all patients have completed therapy, up to 4 years after last patient is enrolled ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   2-Year Event Free Survival of Patients With Osteosarcoma   [ Time Frame: After all patients have completed therapy, up to 3 years after last patient is enrolled ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   2-Year Overall Survival of Patients With Osteosarcoma   [ Time Frame: After all patients have completed therapy, up to 3 years after last patient is enrolled ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   2-Year Event Free Survival in Patients With Localized Resectable Disease Compared to OS99 Protocol.   [ Time Frame: After all patients have completed therapy, up to 3 years after last patient is enrolled ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   2-Year Overall Survival in Patients With Localized Resectable Disease Compared to OS99 Protocol.   [ Time Frame: After all patients have completed therapy, up to 3 years after last patient is enrolled ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Accrual to this study was stopped early after 4.5 years due to slow accrual of participants. No eligible participants were enrolled on Stratum B. All enrolled participants continue on study and results will be reported when available.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Fariba Navid, MD
Organization: St. Jude Children's Research Hospital
phone: 866-278-5833
e-mail: info@stjude.org


No publications provided


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00667342     History of Changes
Other Study ID Numbers: OS2008, GENENTECH PHARM
Study First Received: April 24, 2008
Results First Received: June 9, 2014
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board