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A Phase II, Multicenter, Open-Label Trial of the Safety and Efficacy of Tarceva (Erlotinib Hydrochloride) in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase II, Multicenter, Open-Label Trial of the Safety and Efficacy of Tarceva (Erlotinib Hydrochloride) in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)

Inclusion Criteria:

- Signed informed consent

- Age >= 18 years

- Histologically confirmed GBM in first relapse

- Disease progression in those patients following prior implantation with Gliadel(R)
wafer(s) (polifeprosan 20 with carmustine implant) must be confirmed by biopsy.
Prior therapy with Gliadel(R) is allowed only as a component of primary surgery.
Patients with Gliadel(R) implants after a secondary resection are not eligible.

- Radiographic evidence of disease progression, as assessed by the investigator, on
magnetic resonance imaging (MRI) or CT scan

- Bi-dimensionally measurable disease with a minimum measurement of 1 cm on MRI or CT
scan performed within 14 days prior to study entry

- Prior radiotherapy

- Availability of tissue to allow central confirmation of GBM diagnosis (all original
slides are preferred)

- Availability of paraffin blocks or slides to allow determination of EGFR
amplification status

- Recovery from the toxic effects of a prior therapy, including 4 weeks from prior
cytotoxic agents (except 6 weeks from prior nitrosoureas, 3 weeks from prior
procarbazine administration, 2 weeks from prior vincristine, or 3 weeks from
irinotecan [CPT-11] when given on a weekly schedule), 4 weeks from any prior
investigational agent, and 1 week from prior non-cytotoxic agents (e.g., interferon,
tamoxifen, thalidomide, 13-cis-retinoic acid, etc.)

- If receiving corticosteroids, patients must be on a stable, non-increasing dose of
corticosteroids for >= 2 weeks prior to baseline MRI scan

- ECOG performance status of 0 or 1

- Life expectancy > 12 weeks

- Use of an effective means of contraception in males and in females of childbearing

- Ability to comply with study and follow-up procedures If the decision is made at the
end of Stage 1 to enroll patients with tumors known to be positive for EGFR
amplification, the following additional inclusion criteria will be applied:
Confirmation of diagnosis; Confirmation of positive EGFR amplification status

Exclusion Criteria:

- Prior treatment with Gleevec (e.g., imatinib mesylate) or agents directed at EGFR
(e.g., Iressa)

- Prior treatment with Gliadel(R) following second (salvage or debulking) therapy

- History of any other malignancy within 5 years (except non-melanoma skin cancer or
carcinoma in situ of the cervix)

- More than one prior chemotherapy regimen

- ANC < 1500/uL

- Platelets < 100,000/uL

- Total bilirubin > 1.6 mg/dL

- AST/ALT >= 2.5 x upper limit of normal (ULN)

- Creatinine > 1.5 x ULN

- Pregnant or nursing females

- Unstable systemic disease, including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, or myocardial infarction within 6 months
prior to study entry, or serious cardiac arrhythmia requiring medication

- Major surgical procedure 2 weeks prior to study entry or anticipation of need for
major surgical procedure during the course of the study

- Inability to take oral medication

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara Klencke, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

October 2005

Related Keywords:

  • Glioblastoma
  • Glioblastoma Multiforme
  • glioma
  • Grade IV glioma
  • Glioblastoma
  • Glioma