Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Adult Brain Tumors

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria

INclusion Criteria:

- 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

- Measurable or evaluable disease by contrast MRI

- Must have failed prior treatment that included external beam radiotherapy with or
without chemotherapy

- Epidermal growth Factor Receptor-positive and PTEN wild-type by immunohistochemistry


- 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


- 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

Exclusion Criteria:

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

- Patients must not have any disease that will obscure toxicity or dangerously alter
drug metabolism.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Response Measured Objectively by MRI of Brain

Outcome Description:

Lack of disease progression indicates response to treatment

Outcome Time Frame:

Every 8 weeks or as indicated

Safety Issue:


Principal Investigator

Michael D. Prados, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

March 2009

Related Keywords:

  • Adult Brain Tumors
  • adult glioblastoma
  • adult gliosarcoma
  • recurrent adult brain tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115