NCT00667342 · STUDY IN CONTEXT

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.

Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.

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primary · POSTED

To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.

Source null

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secondary · POSTED

The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.

All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.

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secondary · POSTED

Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.

All the 42 evaluable participants were included in this analysis.

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secondary · POSTED

Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.

All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.

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secondary · POSTED

The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.

OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-osteosarcoma
nct id: NCT00667342
trial label: A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0000
source section id
NCT00667342-om-0000
source outcome index
0
endpoint
Number of Participants With Unacceptable Toxicity
endpoint definition
Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
time origin
After all patients have completed therapy, up to 1 year after last patient is enrolled
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Due to slow accrual, the trial was closed to accrual early. Thus, only 31 stratum A patients and 12 stratum B or C patients were enrolled on the study. Therefore, based on the number of patients enrolled and the designed power for the study, we do not have confidence in making a conclusion regarding this feasibility objective.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0001
source section id
NCT00667342-om-0001
source outcome index
1
endpoint
3-Year Event Free Survival
endpoint definition
To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.
time origin
After all patients have completed therapy, up to 4 years after last patient is enrolled
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0002
source section id
NCT00667342-om-0002
source outcome index
2
endpoint
Histologic Response by Stratum
endpoint definition
The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.
time origin
After 6 cycles of chemotherapy, up to 1 year after the start of therapy
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0003
source section id
NCT00667342-om-0003
source outcome index
3
endpoint
2-Year Event Free Survival (EFS) of Patients With Osteosarcoma
endpoint definition
Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
time origin
After all patients have completed therapy, up to 2 years after last patient is enrolled
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All the 42 evaluable participants were included in this analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0004
source section id
NCT00667342-om-0004
source outcome index
4
endpoint
2-Year Overall Survival (OS) of Patients With Osteosarcoma
endpoint definition
Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
time origin
After all patients have completed therapy, up to 2 years after last patient is enrolled
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0005
source section id
NCT00667342-om-0005
source outcome index
5
endpoint
2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.
endpoint definition
The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.
time origin
After all patients have completed therapy, up to 2 years after last patient is enrolled
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0000
arm key
OG000
arm label
A: Localized Resectable Disease
regimen
Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0000
arm key
OG001
arm label
C: Metastatic Tumors
regimen
Stratum C participants had metastatic tumors.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0001
arm key
OG000
arm label
A: Localized Resectable Disease
regimen
OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0002
arm key
OG000
arm label
A: Localized Resectable Disease
regimen
Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0002
arm key
OG001
arm label
C: Metastatic Tumors
regimen
Stratum C participants had metastatic tumors.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0003
arm key
OG000
arm label
All Participants
regimen
All the 42 evaluable participants in this study had osteosarcoma, of which 22 had events and 20 had no event.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0004
arm key
OG000
arm label
All Participants
regimen
All 42 evaluable participants were included in this analysis
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
outcome key
om-0005
arm key
OG000
arm label
A: Localized Resectable Disease
regimen
OS2008 Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00667342-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
harm key
EG000
source section id
NCT00667342-ae
event group key
EG000
event group label
A: Localized Resectable Disease
serious affected
3
serious at risk
31
other affected
31
other at risk
31
frequency threshold
5
collection period
Adverse events were recorded from on-study date through April 2015.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma
nct id
NCT00667342
harm key
EG001
source section id
NCT00667342-ae
event group key
EG001
event group label
C: Metastatic Tumors
serious affected
0
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
Adverse events were recorded from on-study date through April 2015.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice