Trial · NCT00671970
Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG)
NCT00671970, Phase 2, Completed, Duke University; results first posted 2013-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG). Trials, record NCT00671970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00671970
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG)
- NCT number
- NCT00671970
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Glioblastoma, Gliosarcoma
- Interventions
- Bevacizumab and Erlotinib
- First posted
- 2008-05-06
- Last updated
- 2013-05-13
- Results first posted
- 2013-05-13
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Month Progression-free Survival | 6 months | The proportion of patients alive and progression free at 6 months |
| Secondary | Radiographic Response | Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants | The number of participants with complete or partial response as determined by the following criteria: * Complete response (CR): Disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. * Partial response (PR): Greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose. |
| Secondary | Pharmacokinetics of Erlotinib: Cmax | Day 1 and 42 of Dosing Erlotinib | Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Maximum Concentration (ng/mL) (Cmax) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib |
| Secondary | Pharmacokinetics of Erlotinib: AUC | Day 1 and 42 of Dosing Erlotinib | Day 1 and Day 42 of Dosing Erlotinib in Cycle 1: Area under the Curve (ng/mL.h) (AUC) for subjects receiving 500 mg (Enzyme-Inducing Anti-epileptic Drug, EIAED) or 200 mg (non-EIAED) Erlotinib |
| Secondary | Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR) | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers. |
| Secondary | Association of Biomarkers and One-year Survival - EGFR vIII | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers. |
| Secondary | Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN) | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers. |
| Secondary | Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT) | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers. |
| Secondary | Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK) | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry for biomarkers. |
| Secondary | Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF) | 1 year | Archival tumor samples from grade IV participants were examined by immunohistochemistry (IHC) for biomarkers. The IHC expression score is the product of the percentage of cancer cells positive for VEGF multiplied by the overall intensity of staining, ranging from 0 to 3+. This produces a score ranging from 0 to 300. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Month Progression-free Survival | 6 months | proportion of participants | NUMBER | |
| SECONDARY | Radiographic Response | Patients were followed for the duration of the study, with a median follow-up of 103 weeks for grade III participants and 141.8 weeks for grade IV participants | participants | NUMBER | |
| SECONDARY | Pharmacokinetics of Erlotinib: Cmax | Day 1 and 42 of Dosing Erlotinib | 22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib | ng/ml | MEDIAN |
| SECONDARY | Pharmacokinetics of Erlotinib: AUC | Day 1 and 42 of Dosing Erlotinib | 22 WHO Grade IV participants were available for pharmacokinetics studies of erlotinib | ng/ml.h | MEDIAN |
| SECONDARY | Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR) | 1 year | Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis | participants | NUMBER |
| SECONDARY | Association of Biomarkers and One-year Survival - EGFR vIII | 1 year | Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. | participants | NUMBER |
| SECONDARY | Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN) | 1 year | Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. One tumor had an insufficient measurement for analysis. | participants | NUMBER |
| SECONDARY | Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT) | 1 year | Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Four tumors had an insufficient measurement for analysis. | participants | NUMBER |
| SECONDARY | Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK) | 1 year | Tumors from 22 GBM participants were available to undergo immunohistochemical staining to identify potential biomarkers of response or survival benefit. Six tumors had an insufficient measurement for analysis. | participants | NUMBER |
| SECONDARY | Association of Biomarkers and One-year Survival - Vascular Endothelial Growth Factor (VEGF) | 1 year | IHC Expression Score | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Month Progression-free Survival | Who Grade III | .438 | 95% Confidence Interval .265 to .598 | proportion of participants | |
| 6 Month Progression-free Survival | WHO Grade IV | .292 | 95% Confidence Interval .130 to .476 | proportion of participants | |
| Radiographic Response | Who Grade III | Complete | 1 | participants | |
| Radiographic Response | WHO Grade IV | Complete | 1 | participants | |
| Radiographic Response | Who Grade III | Partial | 9 | participants | |
| Radiographic Response | WHO Grade IV | Partial | 11 | participants | |
| Pharmacokinetics of Erlotinib: Cmax | WHO Grade IV | Day1 Cmax{ng/ml}200mg n=12 | 794 | Full Range 524 to 2200 | ng/ml |
| Pharmacokinetics of Erlotinib: Cmax | WHO Grade IV | Day1 Cmax{ng/ml}500mg n=10 | 1323 | Full Range 317 to 2990 | ng/ml |
| Pharmacokinetics of Erlotinib: Cmax | WHO Grade IV | Day42 Cmax{ng/ml}200mg n=9 | 1320 | Full Range 525 to 2940 | ng/ml |
| Pharmacokinetics of Erlotinib: Cmax | WHO Grade IV | Day42 Cmax{ng/ml}500mg n=9 | 1400 | Full Range 716 to 3955 | ng/ml |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | WHO Grade III | 32 | |
| Overall Study | STARTED | WHO Grade IV | 25 | |
| Overall Study | COMPLETED | WHO Grade III | 32 | |
| Overall Study | COMPLETED | WHO Grade IV | 25 | |
| Overall Study | NOT COMPLETED | WHO Grade III | 0 | |
| Overall Study | NOT COMPLETED | WHO Grade IV | 0 |
Source ClinicalTrials.gov
Adverse events90
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 | Anemia | Blood and lymphatic system disorders | All Patients | 10 | 57 | |
| other | Blurred vision | Eye disorders | All Patients | 14 | 57 | |
| other | Constipation | Gastrointestinal disorders | All Patients | 13 | 57 | |
| other | Diarrhea | Gastrointestinal disorders | All Patients | 28 | 57 | |
| other | Mucositis oral | Gastrointestinal disorders | All Patients | 15 | 57 | |
| other | Nausea | Gastrointestinal disorders | All Patients | 14 | 57 | |
| other | Vomiting | Gastrointestinal disorders | All Patients | 5 | 57 | |
| other | Edema limbs | General disorders | All Patients | 4 | 57 | |
| other | Fatigue | General disorders | All Patients | 40 | 57 | |
| other | Fever | General disorders | All Patients | 3 | 57 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 52 | 57 |
| Total, serious adverse events | All Patients | 20 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20716591 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Positive Expression vs Negative Expression: Association of Biomarkers and One-year Survival - Phosphorylated Mitogen-activated Protein Kinase (pMAPK) | Trial comparisons |
| Positive Expression vs Negative Expression: Association of Biomarkers and One-year Survival - Epidermal Growth Factor (EGFR) | Trial comparisons |
| Positive Expression vs Negative Expression: Association of Biomarkers and One-year Survival - Phosphorylated Protein Kinase B (pAKT) | Trial comparisons |
| Intact vs Loss: Association of Biomarkers and One-year Survival - Phosphatase and Tensin Homologue (PTEN) | Trial comparisons |
| Positive Expression vs Negative Expression: Association of Biomarkers and One-year Survival - EGFR vIII | 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/NCT00671970
GET https://conductscience.org/api/trials/v1/NCT00671970/results?page=2