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Adult Brain TumorsPhase 2NCT00387894

Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

A Phase 2 study testing erlotinib hydrochloride in people with Adult Brain Tumors, run by Michael Prados at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Brain Tumors
What is being tested?
erlotinib hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jan 2007to Mar 2009
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

  • Diagnosis of glioblastoma multiforme (GBM) or gliosarcoma (GS)
  • In first, second, or third relapse
  • History of low-grade glioma with transformation to GBM or GS allowed
  • Considered to be in first relapse at first documented diagnosis of GBM or GS
  • Measurable or evaluable disease by contrast MRI
  • Must have failed prior treatment that included external beam radiotherapy with or without chemotherapy
Show all 34Show fewer
  • Epidermal growth Factor Receptor-positive and PTEN wild-type by immunohistochemistry
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 60-100%
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)
  • SGOT < 2 times upper limit of normal (ULN)
  • Bilirubin < 2 times ULN
  • Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective hormonal or barrier method contraception before, during, and for at least 12 weeks after completion of study treatment
  • No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infection
  • No other disease that would obscure toxicity or dangerously alter study drug metabolism
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 4 weeks since prior and no concurrent radiotherapy
  • At least 4 weeks since prior and no concurrent cytotoxic chemotherapy agents (e.g., temozolomide) (6 weeks for nitrosoureas)
  • At least 2 weeks since prior and no concurrent noncytotoxic chemotherapy agents
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No prior erlotinib hydrochloride or other epidermal growth factor receptor tyrosine-kinase inhibitors
  • At least 2 weeks since prior enzyme-inducing antiepileptic drugs (EIAEDs), if not used concurrently with study treatment
  • Concurrent continuous use of EIAEDs allowed provided the patient has received the drug for ≥ 2 weeks prior to study treatment
  • No concurrent immunotherapy or anticancer hormonal therapy
  • No other concurrent antineoplastic or antitumor agents

Who cannot join

  • Patients meeting any of the following criteria are ineligible for study entry:
  • 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.
  • 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 14 days prior to treatment. 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. If condoms are used as a barrier contraceptive, a spermicidal agent should be added to ensure that pregnancy does not occur. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Prior treatment with Tarceva, or other EGFR tyrosine-kinase inhibitors will not be allowed.
  • Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Phase-2 Study of Tarceva in Patients With Recurrent EGFR Positive and Phosphatase and Tensin Homolog (PTEN) Wild Type Glioblastoma Multiforme and Gliosarcoma

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with recurrent epidermal growth factor receptor (EGFR)-positive and PTEN wild-type glioblastoma multiforme or gliosarcoma treated with erlotinib hydrochloride.

Secondary

  • Assess the response rate in patients who also EGFRVIII mutant and PTEN wild type glioblastoma multiforme or gliosarcoma.
  • Determine the progression-free survival of patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no).

Patients receive oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may receive additional erlotinib hydrochloride after 1 year at their physician's discretion.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Being tested
erlotinib hydrochloride
Keywords
adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor
Medical subject headings
Brain Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

  • erlotinib hydrochlorideDrug

    Also called Tarceva

    Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

Study groups in NCT00387894
Study groupRoleWhat they receive
erlotinib hydrochloride (Tarceva)ExperimentalDuring the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
Receives: Drug: erlotinib hydrochloride

What is being measured

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

  1. Disease Response Measured Objectively by MRI of Brain

    Lack of disease progression indicates response to treatment

    Measured: Every 8 weeks or as indicated

Secondary outcomes (1)

  1. Duration of Progress-free Survival (PFS)

    Patients with stable or responding disease will continue treatment until tumor progression is determined

    Measured: Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)

Timeline

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

  1. First posted13 Oct 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: Insufficient accrual of population likely to benefit; progression in 6 patients

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00387894
Sponsor's protocol ID
CDR0000492762
Other IDs
UCSF-06102, UCSF-H5941-28905-01, GENENTECH-OSI3765s
Status last verified
Apr 2013
First submitted
12 Oct 2006
Last updated
4 Jun 2013
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing erlotinib hydrochloride in people with Adult Brain Tumors, run by Michael Prados 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 34 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Jun 2013. 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 17 May 2013). 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?

Disease Response Measured Objectively by MRI of Brain (time frame: Every 8 weeks or as indicated). 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 NCT00387894.

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 4 Jun 2013.

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