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Glioblastoma MultiformePhase 2NCT00187486

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

A Phase 2 study testing Tarceva, Temodar and Radiation Therapy in people with Glioblastoma Multiforme and Gliosarcoma, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme, Gliosarcoma
What is being tested?
Tarceva, Temodar and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Aug 2004to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 28Show fewer
  • 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.
  • Patients must be 18 years or older, and with a life expectancy > 12 weeks.
  • Patients must have a Karnofsky performance status of > 60.
  • Patients must have adequate bone marrow function (WBC > 3,000/µl, ANC > 1,500/mm^3, platelet count of > 100,000/mm^3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT, and bilirubin < 2 times ULN), and adequate renal function (creatinine < 1.5 mg/dL or calculated creatinine clearance > 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
  • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
  • This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race.
  • Patients must not have active infection.
  • Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
  • Women of childbearing potential must have a negative B-HCG pregnancy test documented within 7 days prior to registration.
  • Patients must not be pregnant because of the uncertainty that study drug may be potentially embryotoxic. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and continue approximately 12 weeks after the study is completed. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
  • Patients must not have serious inter-current medical illness.
  • Patient with recent thromboembolic disease (deep vein thrombosis and pulmonary embolism) are eligible if they are clinically stable and the thromboembolic event occurred more than 3 weeks prior to enrollment into this protocol.

Who cannot join

  • Patients who do not meet one or more of the inclusion criteria above.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Department of Neurological Surgery

    San Francisco, California, 94143-0372

Other trials in United States

About this study

Official title: Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma

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.

Read the detailed description

This is a Phase II Study of Tarceva plus Temodar during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma. The efficacy and safety profile of Tarceva in combination with radiation therapy plus Temodar will be studied. In addition, correlations between response to treatment and epidermal growth factor receptor (EGFR) status as well as other molecular markers of tumor prior to treatment will be explored. Patients will be stratified according to enzyme inducing anti epileptic drug (EIAED) use. Group A (not on EIAEDs) will take 100 milligrams (mg) Tarceva/day during radiotherapy and start with a dose of 150 mg Tarceva/day two weeks after radiotherapy. Group B (on EIAEDs) will take 200mg Tarceva/day during radiotherapy and start with a dose of 300 mg Tarceva/day two weeks after radiotherapy. Both groups will take 75 mg/m^2 Temodar/day during radiotherapy and 200 mg/m^2 Temodar/day x 5 two weeks after radiotherapy. Intrapatient Tarceva dose escalation may occur every two weeks after radiotherapy until the appearance of a particular rash severity. The maximum dose allowed is 200 mg for group A and 500 mg for group B.

Being tested
Tarceva, Temodar, Radiation Therapy
Keywords
Glioblastoma Multiforme, Gliosarcoma, GBM, GS, Tarceva, Temodar, Radiation, Newly Diagnosed
Medical subject headings
Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarcevaDrug

    Also called erlotinib

    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

  • TemodarDrug

    Also called temozolomide

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

  • Radiation TherapyProcedure or surgery

    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.

Study groups in NCT00187486
Study groupRoleWhat they receive
Temodar plus Tarceva plus Radiation TherapyExperimentalSingle arm phase-2 experimental treatment of newly diagnosed patients with Glioblastoma with Temodar plus Tarceva plus Radiation Therapy
Receives: Drug: Tarceva; Drug: Temodar; Procedure: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Patients were monitored until death

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

Secondary outcomes (1)

  1. Progression Free Survival

    Progression based on MR imaging using the Modified McDonnald Criteria defined as 25% increase in sum of products of all measured lesions or any new lesion

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00187486
Sponsor's protocol ID
CC 04101
Other IDs
OSI 2725s
Status last verified
Aug 2017
First submitted
13 Sep 2005
Last updated
5 Sep 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19075262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarceva, Temodar and Radiation Therapy in people with Glioblastoma Multiforme and Gliosarcoma, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: assessment of survival was every 2 months, up to 181 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00187486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

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