Trial · NCT00667342
A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
NCT00667342, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2014-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma. Trials, record NCT00667342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00667342
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma
- NCT number
- NCT00667342
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Osteosarcoma, Malignant Fibrous Histiocytoma (MFH) of Bone
- Interventions
- Bevacizumab, Cisplatin, Doxorubicin, Methotrexate, Ifosfamide, etoposide, Surgery, Radiotherapy
- First posted
- 2008-04-28
- Last updated
- 2023-08-07
- Results first posted
- 2014-08-04
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Unacceptable Toxicity | After all patients have completed therapy, up to 1 year after last patient is enrolled | 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. |
| Primary | 3-Year Event Free Survival | After all patients have completed therapy, up to 4 years after last patient is enrolled | 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. |
| Secondary | Histologic Response by Stratum | After 6 cycles of chemotherapy, up to 1 year after the start of therapy | 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. |
| Secondary | 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma | After all patients have completed therapy, up to 2 years after last patient is enrolled | Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. |
| Secondary | 2-Year Overall Survival (OS) of Patients With Osteosarcoma | After all patients have completed therapy, up to 2 years after last patient is enrolled | Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab. |
| Secondary | 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. | After all patients have completed therapy, up to 2 years after last patient is enrolled | 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. |
| Secondary | 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. | After all patients have completed therapy, up to 2 years after last patient is enrolled | The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here. |
| Secondary | Mean Ktrans | Baseline through Week 10 | The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. |
| Secondary | Mean Vp | Baseline through Week 10 | The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. |
| Secondary | Mean Ve | Baseline through Week 10 | The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Unacceptable Toxicity | After all patients have completed therapy, up to 1 year after last patient is enrolled | 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. | participants | NUMBER |
| PRIMARY | 3-Year Event Free Survival | After all patients have completed therapy, up to 4 years after last patient is enrolled | Probability | NUMBER | |
| SECONDARY | Histologic Response by Stratum | After 6 cycles of chemotherapy, up to 1 year after the start of therapy | All Stratum A participants were evaluated. The tumor sample for analysis was not obtained for one of the 12 Stratum C participants. | participants | NUMBER |
| SECONDARY | 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma | After all patients have completed therapy, up to 2 years after last patient is enrolled | All the 42 evaluable participants were included in this analysis. | probability | NUMBER |
| SECONDARY | 2-Year Overall Survival (OS) of Patients With Osteosarcoma | After all patients have completed therapy, up to 2 years after last patient is enrolled | All the 42 evaluable participants in this study had osteosarcoma, of which 12 died and 20 were still alive as of 05/04/2015. | probability | NUMBER |
| SECONDARY | 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. | After all patients have completed therapy, up to 2 years after last patient is enrolled | OS2008 Localized Resectable Disease group had 31 participants: 14 had events, 17 had no events. | probability | NUMBER |
| SECONDARY | 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. | After all patients have completed therapy, up to 2 years after last patient is enrolled | OS2008 Localized Resectable Disease group had 31 participants: 7 were expired and 24 still alive | probability | NUMBER |
| SECONDARY | Mean Ktrans | Baseline through Week 10 | The number analyzed at each time point differed due to missing observations at some of the time points | min(-1) | MEAN |
| SECONDARY | Mean Vp | Baseline through Week 10 | The number analyzed at each time point differed due to missing observations at some of the time points | (unitless) | MEAN |
| SECONDARY | Mean Ve | Baseline through Week 10 | The number analyzed at each time point differed due to missing observations at some of the time points | (unitless) | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group82
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Unacceptable Toxicity | A: Localized Resectable Disease | Grade 4 Hypertension | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | C: Metastatic Tumors | Grade 4 Hypertension | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | A: Localized Resectable Disease | Grade 4 Proteinuria | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | C: Metastatic Tumors | Grade 4 Proteinuria | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | A: Localized Resectable Disease | Grade 4 Bleeding | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | C: Metastatic Tumors | Grade 4 Bleeding | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | A: Localized Resectable Disease | Grade 3/4 Thrombosis/Embolism | 1 | participants | |
| Number of Participants With Unacceptable Toxicity | C: Metastatic Tumors | Grade 3/4 Thrombosis/Embolism | 0 | participants | |
| Number of Participants With Unacceptable Toxicity | A: Localized Resectable Disease | Grade 2, 3 or 4 Major Wound Complication | 7 | participants | |
| Number of Participants With Unacceptable Toxicity | C: Metastatic Tumors | Grade 2, 3 or 4 Major Wound Complication | 2 | participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Localized Resectable Disease | 31 | |
| Overall Study | STARTED | B: Localized Unresectable Disease | 0 | |
| Overall Study | STARTED | C: Metastatic Tumors | 12 | |
| Overall Study | COMPLETED | A: Localized Resectable Disease | 17 | |
| Overall Study | COMPLETED | B: Localized Unresectable Disease | 0 | |
| Overall Study | COMPLETED | C: Metastatic Tumors | 3 | |
| Overall Study | NOT COMPLETED | A: Localized Resectable Disease | 14 | |
| Overall Study | NOT COMPLETED | B: Localized Unresectable Disease | 0 | |
| Overall Study | NOT COMPLETED | C: Metastatic Tumors | 9 |
Source ClinicalTrials.gov
Adverse events278
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | A: Localized Resectable Disease | 29 | 31 | 291 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | C: Metastatic Tumors | 10 | 11 | 90 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | A: Localized Resectable Disease | 29 | 31 | 258 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | C: Metastatic Tumors | 10 | 11 | 90 |
| other | Hemoglobin | Blood and lymphatic system disorders | A: Localized Resectable Disease | 30 | 31 | 255 |
| other | Hemoglobin | Blood and lymphatic system disorders | C: Metastatic Tumors | 11 | 11 | 135 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | A: Localized Resectable Disease | 30 | 31 | 230 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | C: Metastatic Tumors | 11 | 11 | 123 |
| other | Platelets | Blood and lymphatic system disorders | A: Localized Resectable Disease | 30 | 31 | 212 |
| other | Platelets | Blood and lymphatic system disorders | C: Metastatic Tumors | 11 | 11 | 137 |
1 to 10 of 278Source ClinicalTrials.gov
See all 278 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Localized Resectable Disease | ||
| Total, all-cause mortality | C: Metastatic Tumors | ||
| Total, other adverse events | A: Localized Resectable Disease | 31 | 31 |
| Total, other adverse events | C: Metastatic Tumors | 11 | 11 |
| Total, serious adverse events | A: Localized Resectable Disease | 3 | 31 |
| Total, serious adverse events | C: Metastatic Tumors | 0 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24637635 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| A: Localized Resectable Disease vs C: Metastatic Tumors: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00667342
GET https://conductscience.org/api/trials/v1/NCT00667342/results?page=2