Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors

NCT00187486 | Completed Phase 2 Results DMC

• 2 other identifiers: CC 04101OSI 2725s
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no "placebo" drug.

Conditions

Glioblastoma Multiforme; Gliosarcoma

Keywords

Glioblastoma Multiforme; Gliosarcoma; GBM; GS; Tarceva; Temodar; Radiation; Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients were monitored until death

  assessment of survival was every 2 months, up to 181 weeks

Secondary Outcomes (1)

• Progression Free Survival

  every 2 months measure by MR imaging, up to 39 months

Study Arms (1)

Temodar plus Tarceva plus Radiation Therapy

EXPERIMENTAL

Single arm phase-2 experimental treatment of newly diagnosed patients with Glioblastoma with Temodar plus Tarceva plus Radiation Therapy

Drug: Tarceva; Drug: Temodar; Procedure: Radiation Therapy

Interventions

Tarceva DRUG

Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status

Also known as: erlotinib

Temodar plus Tarceva plus Radiation Therapy

Temodar DRUG

Temodar 200 mg/m\^2/day x 5 days every 28 days

Also known as: temozolomide

Temodar plus Tarceva plus Radiation Therapy

Radiation Therapy PROCEDURE

Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.

Temodar plus Tarceva plus Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven intracranial glioblastoma multiforme (GBM) and gliosarcoma (GS) will be eligible for this protocol.
• Diagnosis will have been established by biopsy or resection no more than 5 weeks prior to treatment.
• An magnetic resonance imaging (MRI) or computer tomography (CT) must be obtained within 14 days of treatment. The use of MRI rather than CT is preferred. The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for assessment of tumor status.
• Patients without measurable or assessable disease are eligible.
• Patient must not have had prior cranial radiation therapy.
• Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors.
• Patients who received Gliadel wafers at the time of original resection will be excluded.
• Patients must have a plan to begin partial brain radiotherapy the same day as Tarceva and temozolomide.
• Radiotherapy must be a) at the Radiation Oncology Department of the University of California San Francisco or b) at an affiliated site such that a radiation oncologist at UCSF can provide assurance that radiation can be performed as specified.
• Radiotherapy must be given by external beam to a partial brain field in daily fractions of 1.8 to 2.0 Gy, to a planned total dose to the tumor of 5940-6100 cGy.
• Stereotactic radiosurgery and brachytherapy will not be allowed.
• Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with Tarceva and temozolomide.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Patients must be registered in the UCSF Neuro-Oncology database prior to treatment with study drug.
• Patients must sign an authorization for the release of their protected health information.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UCSF Department of Neurological Surgery

San Francisco, California, 94143-0372, United States

Location

Related Publications (1)

• Prados MD, Chang SM, Butowski N, DeBoer R, Parvataneni R, Carliner H, Kabuubi P, Ayers-Ringler J, Rabbitt J, Page M, Fedoroff A, Sneed PK, Berger MS, McDermott MW, Parsa AT, Vandenberg S, James CD, Lamborn KR, Stokoe D, Haas-Kogan DA. Phase II study of erlotinib plus temozolomide during and after radiation therapy in patients with newly diagnosed glioblastoma multiforme or gliosarcoma. J Clin Oncol. 2009 Feb 1;27(4):579-84. doi: 10.1200/JCO.2008.18.9639. Epub 2008 Dec 15.

  PMID: 19075262 RESULT

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Interventions

Erlotinib Hydrochloride; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Therapeutics

Results Point of Contact

• Title: Michael Prados, MD
• Organization: University of California San Francisco

PradosM@neurosurg.ucsf.edu

415 353 2076

Study Officials

• Michael Prados, MD

  UCSF Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 5, 2017
• Results First Posted: September 27, 2012

Record last verified: 2017-08

Locations

US (1)