| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02490 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NCI-03-C-0114 | |||
| CDR0000256358 | |||
| NABTC-01-03 | Other Identifier | North American Brain Tumor Consortium | |
| NABTC-01-03 | Other Identifier | CTEP | |
| U01CA062399 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
OBJECTIVES:
Phase 1 I. Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma.
II. Determine the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
Phase 2 I. Determine the 6-month progression-free survival (recurrent malignant glioma) II.12-month survival of patients treated with this drug (stable glioblastoma post radiation therapy)
Phase 2 - Secondary Recurrent Malignant Glioma I. Objective Tumor Response rate associated with erlotinib therapy in recurrent or progressive malignant glioma.
III. 12-month survival of patients treated with this drug Determine the safety profile of this drug in these patients. IV.. Determine the pharmacokinetics of this drug in these patients
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to study phase (I vs II), concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no), histology (recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM), preoperative candidacy (yes vs no), and concurrent steroids (yes vs no).
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose. Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.
Patients are followed for survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Dose Escalation | Experimental | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study. |
|
| Phase 2 recurrent malignant gliomas and nonprogressive GBM | Experimental | Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose (150mg/day. patients requiring surgery treated 7 days prior to tumor removal (150mg/day) PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I | DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib. | 28 days |
| Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts | standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. | cycle 1 - 28 days |
| 6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II) | Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1 | CTCAE | 1 year |
| 1 Year Survival - Phase II Newly Diagnosed GBM Post RT | 12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT |
Not provided
Inclusion Criteria:
One of the following diagnoses:
Histologically confirmed intracranial malignant glioma
Histologically or radiographically confirmed recurrent or progressive benign or malignant meningioma
Progressive disease or tumor recurrence on MRI or CT scan
Patients with progressive disease must have failed prior radiotherapy* that was completed at least 4 weeks ago
Measurable or evaluable disease
Performance status - Karnofsky 60-100%
More than 8 weeks
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 mg/dL (transfusion allowed)
Bilirubin less than 1.5 times upper limit of normal (ULN)
SGOT less than 1.5 times ULN
Creatinine less than 1.5 mg/dL
None of the following ophthalmic abnormalities:
Patients found to have dry eyes on examination but have an otherwise normal examination allowed
No active infection
No other serious concurrent medical illness
No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other disease that would obscure toxicity or dangerously alter drug metabolism
No significant medical illness that would preclude study participation
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 12 weeks after study participation
See Disease Characteristics
At least 1 week since prior thalidomide
At least 1 week since prior interferon
At least 4 weeks since prior SU5416 or other experimental biologic agents
See Disease Characteristics
No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel wafers]) for patients with stable GBM
At least 2 weeks since prior vincristine
At least 3 weeks since prior procarbazine
At least 6 weeks since prior nitrosoureas
At least 1 week since prior tamoxifen
See Disease Characteristics
Recovered from prior radiotherapy
No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression
Recovered from prior surgery
Recovered from prior therapy
At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers
At least 4 weeks since prior cytotoxic therapy
At least 4 weeks since prior tipifarnib or imatinib mesylate
No prior erlotinib or other epidermal growth factor receptor inhibitors
No concurrent combination antiretroviral therapy for HIV-positive patients
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lauren Abrey, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20150371 | Background | Raizer JJ, Abrey LE, Lassman AB, Chang SM, Lamborn KR, Kuhn JG, Yung WK, Gilbert MR, Aldape KD, Wen PY, Fine HA, Mehta M, Deangelis LM, Lieberman F, Cloughesy TF, Robins HI, Dancey J, Prados MD; North American Brain Tumor Consortium. A phase I trial of erlotinib in patients with nonprogressive glioblastoma multiforme postradiation therapy, and recurrent malignant gliomas and meningiomas. Neuro Oncol. 2010 Jan;12(1):87-94. doi: 10.1093/neuonc/nop017. Epub 2009 Dec 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects enrolled between August 15, 2002 and August 18, 2005. Patient recruited from outpatient oncology centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 Dose Escalation | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 100mg Phase 1 Dose Escalalation |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| laboratory biomarker analysis | Other | correlative studies |
|
| pharmacological study | Other | correlative studies |
|
| At 1 year |
| Overall Survival Newly Diagnosed GBM Post RT | Overall Survival defined as Time from Start of treatment to time of death due to any cause | 2 years |
| Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II | Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), 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). | At 1 year |
| Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II | Summarized by descriptive statistics. | Up to 1 year |
| Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. |
| Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| Trough Level Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | cycle 1 day eight |
| Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg- | plasma concentrations relative to erlotiniab administration and sample time and dose level | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | One sample on day 8 cycle 1 |
| Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Drug administered 6 days prior to surgery | Pre-surgery and time of resection |
| Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Drug administered 6 days prior to surgery | Pre-surgery and time of resection |
| San Francisco |
| California |
| 94115 |
| United States |
| National Cancer Institute Neuro-Oncology Branch | Bethesda | Maryland | 20814 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| FG001 | Phase 2 - Recurrent Malignant Glioma | Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose. Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. |
| FG002 | Phase 2 - Newly Diagnosed GBM Post RT | Patients with GBM with newly diagnosed disease following Radiation (RT) started erlotinib no more than 6 weeks from the completion of RT. Temozolomide or other adjuvant chemotherapy not allowed while on erotinib |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 200mg Phase 1 Dose Escalation |
|
| 275mg Phase 1 Dose Escalation |
|
| 400mg Phase 1 Dose Escalation |
|
| 525mg Phase 1 Dose Escalation |
|
| 650mg Phase 1 Dose Escalation |
|
| 775mg Dose Escalation |
|
enrolled between 8/2002 and 8/2005. All recruited from outpatient setting.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 Dose Escalation | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. |
| BG001 | Phase 2 w/ Recurrent Malignant Glioma | Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib at a predetermined dose (150mg/day). Patients requiring surgery were treated 7 days prior to tumor removal PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis |
| BG002 | Phase 2 Newly Diagnosed GBM Post RT | Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. (150mg/day) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Histology | Number | participants |
| ||||||||||||||||
| Prior Radiation Treatment | Number | participants |
| ||||||||||||||||
| Prior Number of Chemotherapy Regimens | Number | participants |
| ||||||||||||||||
| Karnofsky Performance Status Scale | Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death | Median | Full Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I | DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib. | Patients were eligible if they had recurrent disease or if they were newly diagnosed post RT and did NOT have tumor progression (nonprogression glioblastoma) on Enzyme-inducing Antiepileptic Drugs | Posted | Number | dose limiting toxicities | 28 days |
|
|
| ||||||||||||||||||||||||||||
| Primary | Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts | standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. | Cohorts/dose levels: 150mg; 200mg; 275mg; 400mg; 525mg; 650mg; 775mg patients on Enzyme-inducing Antiepileptic Drugs | Posted | Number | mg | cycle 1 - 28 days |
|
| |||||||||||||||||||||||||||||
| Primary | 6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II) | Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), 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). | 38 Glioblastoma, 15 anaplastic gliomas not receiving Enzyme-inducing Antiepileptic Drugs | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1 | CTCAE | During Cycle 1 only grade 3 severity; patients on Enzyme-inducing Antiepileptic Drugs | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | 1 Year Survival - Phase II Newly Diagnosed GBM Post RT | 12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT | not receiving Enzyme-inducing Antiepileptic Drugs; stable glioblastoma after RT | Posted | Number | % of participants | At 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival Newly Diagnosed GBM Post RT | Overall Survival defined as Time from Start of treatment to time of death due to any cause | not receiving Enzyme-inducing Antiepileptic Drugs, glioblastoma stable after RT | Posted | Median | 95% Confidence Interval | months | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II | Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), 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). | recurrent malignant gliomas - anaplastic and glioblastoma | Posted | Number | participants | At 1 year |
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II | Summarized by descriptive statistics. | drug related events grade 3-5 CTCAE. 5 patients were not evaluable for response/toxicity. | Posted | Number | percent of participants | Up to 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | tmax=time of peak plasma concentration | Posted | Mean | Standard Deviation | h | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. |
| |||||||||||||||||||||||||||||
| Secondary | Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | Cp=peak plasma concentration; | Posted | Mean | Standard Deviation | ng/mL | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| |||||||||||||||||||||||||||||
| Secondary | Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | AUC=area under the curve | Posted | Mean | Standard Deviation | ug* h/mL | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
| |||||||||||||||||||||||||||||
| Secondary | Trough Level Per Dose Level Phase I (on Anticonvulsants) - | plasma concentrations relative to erlotiniab administration and sample time and dose level | trough level | Posted | Mean | Standard Deviation | ng/mL | cycle 1 day eight |
| |||||||||||||||||||||||||||||
| Secondary | Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | Cpmax =peak plasma concentration; | Posted | Mean | Standard Deviation | ng/mL | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | tmax=time to peak plasma concentration; | Posted | Mean | Standard Deviation | h | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
|
| ||||||||||||||||||||||||||||
| Secondary | Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg- | plasma concentrations relative to erlotiniab administration and sample time and dose level | AUC=area under the curve; | Posted | Mean | Standard Deviation | ug * h/mL | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 |
|
| ||||||||||||||||||||||||||||
| Secondary | Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | plasma concentrations relative to erlotiniab administration and sample time and dose level | Cp=peak plasma concentration; tmax=time to Cp; AUC=area under the curve; | Posted | Mean | Standard Deviation | ng/mL | One sample on day 8 cycle 1 |
|
| ||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Drug administered 6 days prior to surgery | sample 5 and 6 suspected of contamination with blood clot | Posted | Mean | Standard Deviation | plasma concentration ng/mL | Pre-surgery and time of resection |
|
| ||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Drug administered 6 days prior to surgery | sample 5 and 6 suspected of contamination with blood clot tumor/tissue concentration | Posted | Mean | Standard Deviation | tumor/tissue concentration ng/g dry weig | Pre-surgery and time of resection |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 Dose Escalation | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. | 0 | 32 | 27 | 32 | ||
| EG001 | Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm | Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR) erlotinib hydrochloride given orally Other: pharmacological study, laboratory biomarker analysis. | 2 | 99 | 11 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| granulocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren E Abrey, MD | Adult Brain Tumor Consortium | 410-955-8837 | jfisher@jhmi.edu |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D008579 | Meningioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Anaplastic Astrocytoma |
|
| Anaplastic oligodendroglioma |
|
| Atypical meningioma |
|
| Pleomorphic Xanthoastrocytoma |
|
| Oligodendroglioma |
|
| No |
|
| 1 treatment |
|
| 2 treatments |
|
| 3 treatments |
|
|
| Dose 275mg |
|
|
| Dose 400mg |
|
|
| Dose 525mg |
|
|
| Dose 650mg (DVT/PE) |
|
|
| Dose 775mg (Rash [2]) |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG003 | Phase 1 Dose Escalation - 400 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG004 | Phase 1 Dose Escalation - 525 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG005 | Phase 1 Dose Escalation - 650 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG006 | Phase 1 Dose Escalation - 775 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
|
|
| Phase 1 Dose Escalation - 275 mg |
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG003 | Phase 1 Dose Escalation - 400 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG004 | Phase 1 Dose Escalation - 525 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG005 | Phase 1 Dose Escalation - 650 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG006 | Phase 1 Dose Escalation - 775 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
|
|
| Phase 1 Dose Escalation - 275 mg |
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG003 | Phase 1 Dose Escalation - 400 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG004 | Phase 1 Dose Escalation - 525 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG005 | Phase 1 Dose Escalation - 650 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG006 | Phase 1 Dose Escalation - 775 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
|
|
Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined.
The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
| OG003 | Phase 1 Dose Escalation - 400 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG004 | Phase 1 Dose Escalation - 525 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG005 | Phase 1 Dose Escalation - 650 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
| OG006 | Phase 1 Dose Escalation - 775 mg | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
|
|
|
|
|
|
|
|