Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma
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ClinicalTrials.gov Identifier: NCT00301418 |
Recruitment Status :
Completed
First Posted : March 10, 2006
Results First Posted : February 10, 2016
Last Update Posted : February 10, 2016
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma Multiforme Anaplastic Astrocytoma | Drug: Erlotinib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Tarceva (Erlotinib) |
Drug: Erlotinib
Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
Other Names:
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- Safety of Twice a Day Oral 150 mg Erlotinib Dosing [ Time Frame: duration of the trial ]Greater than or equal to Grade 2 Adverse Event
- 6-month Progression Free Survival (PFS) [ Time Frame: Duration of the trial ]
- Overall Survival (OS) [ Time Frame: Duration of the trial ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female patients of ≥ 18 years of age.
- Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA). All patients will have samples of their tissue evaluated for EGFRvIII overexpression and PTEN loss.
- Patients with a histologically confirmed low grade brain tumor who relapse with an enhancing tumor on magnetic resonance imaging (MRI) can be evaluated for toxicity only.
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Patients must have at least one confirmed and evaluable tumor site.*
*A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or computed tomography [CT] scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
- Patients must have a Karnofsky performance status ≥ 60% (or the equivalent Eastern Cooperative Oncology Group [ECOG] level of 0-2) and an expected survival of ≥ three months.
- No chemotherapy for six weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
- Patients must have adequate hematologic reserve with WBC ≥ 3000/mm3, absolute neutrophils ≥ 1500/mm3 and platelets ≥ 100,000/mm3. Patients who are on Coumadin must have a platelet count of ≥ 150,000/mm3
- Pre-enrollment chemistry parameters must show: bilirubin < 1.5X the institutional upper limit of normal (IUNL); AST or ALT < 2.5X IUNL and creatinine < 1.5X IUNL.
- Pre-enrollment coagulation parameters (PT and PTT) must be ≤ 1.5X the IUNL.
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Concomitant Medications:
- Growth factor(s): Must not have received within 1 week of entry onto this study.
- Steroids: Systemic corticosteroid therapy is permissible in patients with centrail nervous system (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
- Study Specific: Patients on enzyme-inducing anticonvulsants will be changed to non-enzyme inducing anticonvulsants or will not be allowed on this study. Patients receiving proton pump inhibitor or H2 blockers will not be allowed on study. Patients taking antacids will be allowed on study although they should not take the antacid for two hours before or two hours after taking erlotinib.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Patients should not have received a CYP3A4 inhibitor within 1 week of study entry and should not have received a CYP3A4 inducer within 4 weeks of study entry.
- Patients should not have received proton-pump inhibitors within 5 days of study entry or H2 blockers within 2 days of study entry.
- Patients on steroids must receive prophylaxis for Pneumocystis carinii pneumonia (PCP) with Bactrim, unless they have a history of allergy to sulfa drugs.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Exclusion Criteria:
- Previous treatment with Tarceva®.
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301418
United States, New York | |
Lenox Hill Brain Tumor Center | |
New York, New York, United States, 10075 |
Principal Investigator: | John A Boockvar, M.D. | Feinstein Institute for Medical Research |
Publications:
Responsible Party: | John A. Boockvar, Professor, Northwell Health |
ClinicalTrials.gov Identifier: | NCT00301418 History of Changes |
Other Study ID Numbers: |
501007705 |
First Posted: | March 10, 2006 Key Record Dates |
Results First Posted: | February 10, 2016 |
Last Update Posted: | February 10, 2016 |
Last Verified: | January 2016 |
Keywords provided by John A. Boockvar, Northwell Health:
Glioblastoma Multiforme Anaplastic Astrocytoma High Grade Glial Neoplasms Brain Tumor |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |