Trial · NCT00433381
Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
NCT00433381, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma. Trials, record NCT00433381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
- NCT number
- NCT00433381
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm
- Interventions
- Bevacizumab, Irinotecan Hydrochloride, Temozolomide
- First posted
- 2007-02-12
- Last updated
- 2018-09-17
- Results first posted
- 2013-05-01
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm | From randomization to six months. | Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months. |
| Primary | Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm) | From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor). | This endpoint determines tolerability of this treatment arm. If tolerable, then the secondary endpoint of treatment efficacy for this arm occurs. Percentage is calculated by taking the number of patients who did not stop bevacizumab and temozolomide treatment due to medical complications in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who did not begin treatment. |
| Primary | Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6) | 2 and 8 weeks posttreatment, and every 2 months until 96wks | Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 6-month progression-free survival (PFS-6) over all study participants. Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to progression, evaluated at 96wks, is the determinate of PFS at 6months (PFS-6). Subjects will not be analyzed by arm. |
| Primary | Number of Participants With Predicted Overall Survival (OS) at 12 Months | 2 and 8 weeks posttreatment, and every 2 months until 96wks | Magnetic Resonance Imaging with Spectroscopy (MRS or MRSI) metabolic tumor ratios will be used to predict 12-month overall survival (OS). Ratios of NAA/Cho, Cho/Cr, NAA/Cr measured at 2 weeks and 8 weeks and every 2 months until 96wks were used to predict survival, and time to death, evaluated at 96wks, is the determinate of OS at 12 months. Subjects will not be analyzed by arm. |
| Secondary | Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm | From randomization to six months. | Progression defined as ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Percentage is calculated by taking the number of patients who have survived 6 months without progression of study disease after study registration in the numerator. The denominator consists of all patients except those who were found retrospectively to be ineligible or who were lost to follow-up after less than 6 months. |
| Secondary | Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression) | From randomization to death or last follow-up. Patients were followed up to 62.9 months. | Tumor size measured in millimeters and is the largest crosssectional area using perpendicular measurements of contrast enhancing abnormality. Complete response (CR): Complete disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off corticosteroids, and neurologically stable or improved. Partial response (PR): ≥ 50% decrease in size of enhancing tumor on consecutive MRI scans at least 1 month apart, corticosteroids stable or reduced, and neurologically stable or improved. Progressive disease (PD): ≥ 25% increase in the size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable or increased. Stable disease (SD): Does not qualify for CR, PR, or PD. |
| Secondary | Agreement Between Local Interpretation and Central Interpretation of Standard MRI | baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment | Local and central interpretations of the standard MRI were assessed for progression and survival at all available imaging (baseline visit, week 2, and after every 2 cycles of treatment, and at termination of treatment). Patients who suffer clinical progression without radiographic confirmation of progression were considered to have progressive disease in determination of PFS-6. Subjects participated in the MR substudies regardless of therapeutic intervention |
| Secondary | Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard | baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment | Local reads were treated as the test and central reads were treated as the reference standard. Thus, a participant meeting the definition of progression on any standard MRI central interpretation (baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment) was considered positive for PFS-6. Therefore, a true positive is defined as a positive local interpretation for a subject with a positive central read. |
| Secondary | Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio | 2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2) | Aim not included in final (February 10, 2009) protocol (removed from section 2). |
| Secondary | Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response | 2 weeks following initiation of protocol treatment (T1) | Aim not included in final (February 10, 2009) protocol (removed from section 2) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm | From randomization to six months. | Eligible patients with six-month data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm) | From randomization to end of treatment (treatment can continue up to 24 months for patients with stable or responding tumor). | The first 29 eligible patients who received protocol treatment were to be evaluated for treatment tolerability. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6) | 2 and 8 weeks posttreatment, and every 2 months until 96wks | A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI.~Of 123 main subjects, a subset of 20 consented to the MRS substudy, of whom 13 had analyzable MRS datasets. this subset is independent of Study Arm. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Predicted Overall Survival (OS) at 12 Months | 2 and 8 weeks posttreatment, and every 2 months until 96wks | A subset of 3 institutions conducted a substudy of advanced MRI, including dynamic contrast enhanced imaging, dynamic susceptibility contrast imaging, and MRSI. Subjects participated in the MR substudies regardless of therapeutic intervention | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm | From randomization to six months. | Eligible patients with six-month data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression) | From randomization to death or last follow-up. Patients were followed up to 62.9 months. | Eligible patients with measurable disease at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Agreement Between Local Interpretation and Central Interpretation of Standard MRI | baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment | Of the 123 subject accrued to ACRIN 6677, 103 were analyzable for this aim. Reasons for exclusions were as follows: 11 subjects only had baseline imaging, 4 were ineligible, 1 was lost to followup, and 4 had incomplete/uninterpretable images. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Accuracy of Local PFS 6-mo Interpretation Using Central Review PFS-6 as the Reference Standard | baseline visit, week 2, after every 2 cycles of treatment, and at termination of treatment | Standard of care MRI occurred at baseline, after every 2 cycles of treatment (every 8 weeks), and after completion/termination of treatment. Subjects participated in the MR substudies regardless of therapeutic intervention | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to N-acetylaspartate (NAA) (Lac/NAA) Ratio | 2 weeks following initiation of protocol treatment (T1) and at 8 weeks following chemotherapy with bevacizumab (T2) | This Aim was removed from the approved protocol aims. Data were not collected. | ||
| SECONDARY | Correlation of Degree of Cerebral Blood Volume (CBV) and Lactate (Lac) to Patient Response | 2 weeks following initiation of protocol treatment (T1) | This Aim was removed from the approved protocol aims. Data were not collected. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Irinotecan Hydrochloride Arm | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 22 | Participants | ||
| Count/Percentage of Patients Discontinuing Treatment Due to Treatment-related Medical Complications(Bevacizumab and Temozolomide Arm) | Arm I (Bevacizumab and Temozolomide) | 6 | Participants | ||
| Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6) | Analyzable MRS Participants | PFS <= 6mo | 4 | Participants | |
| Number of Participants With Predicted Progression-free Survival at 6 Months (PFS-6) | Analyzable MRS Participants | PFS > 6mo | 9 | Participants | |
| Number of Participants With Predicted Overall Survival (OS) at 12 Months | Analyzable MRS Participants | OS <=12mo | 6 | Participants | |
| Number of Participants With Predicted Overall Survival (OS) at 12 Months | Analyzable MRS Participants | OS>12 mo | 7 | Participants | |
| Count/Percentage of Patients Progression-free at 6 Months for Bevacizumab and Temozolomide Arm | Arm I (Bevacizumab and Temozolomide) | 23 | Participants | ||
| Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression) | Arm I (Bevacizumab and Temozolomide) | Complete Response | 2 | Participants | |
| Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression) | Arm II (Bevacizumab and Irinotecan Hydrochloride) | Complete Response | 2 | Participants | |
| Patients' Best Objective Response (Complete Response, Partial Response, Stable Disease, Progression) | Arm I (Bevacizumab and Temozolomide) | Partial Response | 9 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Bevacizumab and Temozolomide) | 63 | |
| Overall Study | STARTED | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 60 | |
| Overall Study | COMPLETED | Arm I (Bevacizumab and Temozolomide) | 60 | |
| Overall Study | COMPLETED | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 57 | |
| Overall Study | NOT COMPLETED | Arm I (Bevacizumab and Temozolomide) | 3 | |
| Overall Study | NOT COMPLETED | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 3 |
Source ClinicalTrials.gov
Adverse events428
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 | Edema: limb: | Blood and lymphatic system disorders | Arm I (Bevacizumab and Temozolomide) | 16 | 60 | |
| other | Edema: limb: | Blood and lymphatic system disorders | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 9 | 57 | |
| other | Epistaxis | Blood and lymphatic system disorders | Arm I (Bevacizumab and Temozolomide) | 14 | 60 | |
| other | Epistaxis | Blood and lymphatic system disorders | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 10 | 57 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm I (Bevacizumab and Temozolomide) | 26 | 60 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 23 | 57 | |
| other | Hemorrhage/bleeding - Other: | Blood and lymphatic system disorders | Arm I (Bevacizumab and Temozolomide) | 3 | 60 | |
| other | Hemorrhage/bleeding - Other: | Blood and lymphatic system disorders | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 0 | 57 | |
| other | Hemorrhagic stroke | Blood and lymphatic system disorders | Arm I (Bevacizumab and Temozolomide) | 3 | 60 | |
| other | Hemorrhagic stroke | Blood and lymphatic system disorders | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 4 | 57 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Bevacizumab and Temozolomide) | ||
| Total, all-cause mortality | Arm II (Bevacizumab and Irinotecan Hydrochloride) | ||
| Total, other adverse events | Arm I (Bevacizumab and Temozolomide) | 55 | 60 |
| Total, other adverse events | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 55 | 57 |
| Total, serious adverse events | Arm I (Bevacizumab and Temozolomide) | 37 | 60 |
| Total, serious adverse events | Arm II (Bevacizumab and Irinotecan Hydrochloride) | 37 | 57 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA021661 | Radiation Therapy Oncology Group | CURRAN, WALTER J. | AMERICAN COLLEGE OF RADIOLOGY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I (Bevacizumab and Temozolomide) vs Arm II (Bevacizumab and Irinotecan Hydrochloride): 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/NCT00433381
GET https://conductscience.org/api/trials/v1/NCT00433381/results?page=2