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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: April 17, 2017
Last verified: April 2017
Results First Received: June 9, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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 
 (6 to 20) 
    12 
 (8 to 20) 
 12 
 (6 to 20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  48.4%         5  41.7%      20  46.5% 
Male      16  51.6%         7  58.3%      23  53.5% 


  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.  Primary:   3-Year Event Free Survival   [ Time Frame: After all patients have completed therapy, up to 4 years after last patient is enrolled ]

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

4.  Secondary:   2-Year Event Free Survival (EFS) of Patients With Osteosarcoma   [ Time Frame: After all patients have completed therapy, up to 2 years after last patient is enrolled ]

5.  Secondary:   2-Year Overall Survival (OS) of Patients With Osteosarcoma   [ Time Frame: After all patients have completed therapy, up to 2 years after last patient is enrolled ]

6.  Secondary:   2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.   [ Time Frame: After all patients have completed therapy, up to 2 years after last patient is enrolled ]

7.  Secondary:   2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.   [ Time Frame: After all patients have completed therapy, up to 2 years after last patient is enrolled ]

8.  Secondary:   Mean Ktrans   [ Time Frame: Baseline through Week 10 ]

9.  Secondary:   Mean Vp   [ Time Frame: Baseline through Week 10 ]

10.  Secondary:   Mean Ve   [ Time Frame: Baseline through Week 10 ]

11.  Secondary:   Histologic Response by Number of Participants   [ Time Frame: at week 10 after start of therapy ]

12.  Secondary:   Ktrans by Good and Poor Response   [ Time Frame: at week 10 after start of therapy ]

13.  Secondary:   P95 of Ktrans by Good and Poor Response   [ Time Frame: at week 10 after start of therapy ]

14.  Secondary:   Difference Between Good and Poor Response by SUVmax   [ Time Frame: at week 10 after start of therapy ]

15.  Other Pre-specified:   Number of Participants With Neuropathic Pain (NP) Following Surgery   [ Time Frame: Up to 6 months postoperatively ]

16.  Other Pre-specified:   Median Duration of Neuropathic Pain   [ Time Frame: From surgery until resolution of NP symptoms, up to 6 months ]

17.  Other Pre-specified:   Mean Duration of Neuropathic Pain   [ Time Frame: From surgery until resolution of NP symptoms, up to 6 months ]

18.  Other Pre-specified:   Median Duration of Neuropathic Pain Medication   [ Time Frame: From surgery until resolution of NP symptoms, up to 6 months ]

19.  Other Pre-specified:   Mean Duration of Neuropathic Pain Medication   [ Time Frame: From surgery until resolution of NP symptoms, up to 6 months ]


  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: Michael Bishop, MD
Organization: St. Jude Children's Research Hospital
phone: 866-278-5833
e-mail: referralinfo@stjude.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00667342     History of Changes
Other Study ID Numbers: OS2008
GENENTECH PHARM ( Other Identifier: Genentech Pharmaceuticals )
NCI-2009-00846 ( Registry Identifier: NCI Clinical Trial Registration Program )
Study First Received: April 24, 2008
Results First Received: June 9, 2014
Last Updated: April 17, 2017