Trial · NCT00720356
Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
NCT00720356, Phase 2, Completed, Northwestern University; results first posted 2018-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma. Trials, record NCT00720356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00720356
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
- NCT number
- NCT00720356
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 115 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- bevacizumab, erlotinib hydrochloride
- First posted
- 2008-07-22
- Last updated
- 2018-10-26
- Results first posted
- 2018-10-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From start of treatment, during treatment and every 3 months following the end of treatment until death. Median follow up at time of OS data was 33 months. | Overall survival (OS) will be measured from the start of treatment until death from any cause. At data cut off patients remaining alive will be censored at the last known date of contact. |
| Secondary | Progression-free Survival at 12 Months | At 12 months from start of treatment | Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death. |
| Secondary | Response Rate (RR) | From the start of treatment, every 2 cycles (1 cycle = 28 days) during treatment until progressive disease | Response Rate (RR) will be defined as the best response seen during treatment measured by CT/MRI scan every 8 weeks during treatment using McDonald Criteria. CR=Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients off steroids. PR=Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable/decreased dose of steroids. Stable/No Response=Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration. Stable/decreased dose of steroids. Progressive disease = 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease), worsening of evaluable disease, new lesions/site, failure to return for evaluation due to death or deteriorating condition. |
| Secondary | Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population | From the start of treatment, at the beginning of every cycle (1 cycle = 28 days) during treatment until 30 days after completion of treatment for up to 49 cycles. | Toxicity data for combination treatment of erlotinib and bevacizumab will be collected on day 1 of every cycle (1 cycle = 28 days) during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
| Secondary | Progression Free Survival at 18 Months | At 18 months from start of treatment | Progression free survival (PFS) will be assessed by CT or MRI scan using McDonald criteria. Progressive disease (PD) is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Stable or increased dose of steroids. PFS will be measured from the start of treatment until first documentation of PD or death. |
| Other | Changes in Tumor Blood Flow Based on MR Perfusion | Prior to study treatment (after surgery, but before radiation), just before study treatment (within 14 days prior to first treatment) and then every 2 cycles during study treatment, where 1 cycle equals 28 days for a maximum of 49 cycles. | Data from consenting patients will be used to assess of changes in tumor blood flow based on MR perfusion using MRI scans. Two scans will be completed prior to treatment on study; the first after surgery buta before radiation, the second within 14 days before starting combination treatment or erlotinib and bevacizumab. Then scans will be completed every 2 cycles during treatment, where one cycle equals 28 days. |
| Other | Gene Methylation Studies (Optional) | At baseline and then plasma only will be collected every odd cycle (1 cycle = 28 days) during treatment for a maximum of 49 cycles. | Tissue and plasma collected from consenting patients in the study will be used to correlate tumor tissue with imaging and outcomes. Tissue will be collected before treatment on study begins and plasma will be collected the first day of treatment (before treatment) and every odd cycle after that, whilst on study treatment. Tissue and plasma analysis will be correlated with patients imaging results and response to to treatment |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From start of treatment, during treatment and every 3 months following the end of treatment until death. Median follow up at time of OS data was 33 months. | 2 patients were not evaluable - 1 patient withdrew consent and 1 patient completed less than 1 cycle of treatment | Months | MEDIAN |
| SECONDARY | Progression-free Survival at 12 Months | At 12 months from start of treatment | Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient completed one cycle) | percentage of patients | NUMBER |
| SECONDARY | Response Rate (RR) | From the start of treatment, every 2 cycles (1 cycle = 28 days) during treatment until progressive disease | Two patients were determined not to be evaluable (one patient withdrew consent from the study and one patient complete one cycle of treatment only) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population | From the start of treatment, at the beginning of every cycle (1 cycle = 28 days) during treatment until 30 days after completion of treatment for up to 49 cycles. | All patients that received at least one dose of study drug were evaluable for toxicity. Data for grade 3 and 4 toxicities during treatment were collected. | patients | NUMBER |
| SECONDARY | Progression Free Survival at 18 Months | At 18 months from start of treatment | Most patients had progressed before the 18 month time point. Data was not collected for PFS at 18 months. | ||
| OTHER_PRE_SPECIFIED | Changes in Tumor Blood Flow Based on MR Perfusion | Prior to study treatment (after surgery, but before radiation), just before study treatment (within 14 days prior to first treatment) and then every 2 cycles during study treatment, where 1 cycle equals 28 days for a maximum of 49 cycles. | This was an optional portion of the study that patients could participate in. Data was not collected or analyzed for this outcome measure. | ||
| OTHER_PRE_SPECIFIED | Gene Methylation Studies (Optional) | At baseline and then plasma only will be collected every odd cycle (1 cycle = 28 days) during treatment for a maximum of 49 cycles. | This was an optional portion of the study for consenting patients. No data was collected and analyzed for this outcome measure. | ||
| POST_HOC | Progression Free Survival at 6 Months | At 6 months from start of treatment | Two patients were not evaluable. | percentage of patients | NUMBER |
| POST_HOC | Overall Survival at 12 Months | At 12 months from start of treatment | Two patients were not evaluable | percentage of patients | NUMBER |
| POST_HOC | Overall Survival at 24 Months | At 24 months from first treatment | Two patients were not evaluable | percentage of patients | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Erlotinib and Bevacizumab Combination Treatment | 13.2 | 95% Confidence Interval 10.8 to 19.6 | Months | |
| Progression-free Survival at 12 Months | Erlotinib and Bevacizumab Combination Treatment | 32 | percentage of patients | ||
| Response Rate (RR) | Erlotinib and Bevacizumab Combination Treatment | Complete Response | 4 | Participants | |
| Response Rate (RR) | Erlotinib and Bevacizumab Combination Treatment | Partial Response | 12 | Participants | |
| Response Rate (RR) | Erlotinib and Bevacizumab Combination Treatment | Stable/no response | 28 | Participants | |
| Response Rate (RR) | Erlotinib and Bevacizumab Combination Treatment | Progressive Disease | 0 | Participants | |
| Response Rate (RR) | Erlotinib and Bevacizumab Combination Treatment | No Evaluable Disease (NED) | 2 | Participants | |
| Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population | Erlotinib and Bevacizumab Combination Treatment | Hyberbilirubinemia | 1 | patients | |
| Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population | Erlotinib and Bevacizumab Combination Treatment | Cerebrovascular ischemia | 1 | patients | |
| Safety of the Combination of Erlotinib and Bevacizumab in This Patient Population | Erlotinib and Bevacizumab Combination Treatment | Dehydration | 1 | patients |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Registration to Study | STARTED | Erlotinib and Bevacizumab Combination Treatment | 115 | |
| Registration to Study | Completed Registration Step 1 | Erlotinib and Bevacizumab Combination Treatment | 115 | |
| Registration to Study | Completed Registration Step 2 | Erlotinib and Bevacizumab Combination Treatment | 48 | |
| Registration to Study | COMPLETED | Erlotinib and Bevacizumab Combination Treatment | 48 | |
| Registration to Study | NOT COMPLETED | Erlotinib and Bevacizumab Combination Treatment | 67 | |
| Reached 1st Response/2 Cycles | STARTED | Erlotinib and Bevacizumab Combination Treatment | 48 | |
| Reached 1st Response/2 Cycles | COMPLETED | Erlotinib and Bevacizumab Combination Treatment | 46 | |
| Reached 1st Response/2 Cycles | NOT COMPLETED | Erlotinib and Bevacizumab Combination Treatment | 2 | |
| Went on to be Treated Cycle 3 | STARTED | Erlotinib and Bevacizumab Combination Treatment | 46 | |
| Went on to be Treated Cycle 3 | COMPLETED | Erlotinib and Bevacizumab Combination Treatment | 44 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events114
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 | Allergic rhinitis | Immune system disorders | Erlotinib and Bevacizumab Combination Treatment | 6 | 48 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Erlotinib and Bevacizumab Combination Treatment | 10 | 48 | |
| other | Leukocytes (total white blood cells) | Blood and lymphatic system disorders | Erlotinib and Bevacizumab Combination Treatment | 11 | 48 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Erlotinib and Bevacizumab Combination Treatment | 25 | 48 | |
| other | Platelets (thrombocytopenia) | Blood and lymphatic system disorders | Erlotinib and Bevacizumab Combination Treatment | 10 | 48 | |
| other | Hypertension | Cardiac disorders | Erlotinib and Bevacizumab Combination Treatment | 12 | 48 | |
| other | Sinus bradycardia | Cardiac disorders | Erlotinib and Bevacizumab Combination Treatment | 3 | 48 | |
| other | Fatigue | General disorders | Erlotinib and Bevacizumab Combination Treatment | 29 | 48 | |
| other | Fever | General disorders | Erlotinib and Bevacizumab Combination Treatment | 3 | 48 | |
| other | Insomnia | General disorders | Erlotinib and Bevacizumab Combination Treatment | 4 | 48 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib and Bevacizumab Combination Treatment | 43 | 48 |
| Total, other adverse events | Erlotinib and Bevacizumab Combination Treatment | 48 | 48 |
| Total, serious adverse events | Erlotinib and Bevacizumab Combination Treatment | 15 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00720356
GET https://conductscience.org/api/trials/v1/NCT00720356/results?page=2