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A Study of the Safety and Efficacy of Tarceva in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337883
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase II, open-label, multicenter trial of single-agent treatment with Tarceva in patients with histologically confirmed GBM in first relapse. This study seeks to estimate the objective response rate and will investigate whether response rate is related to EGFR amplification status.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Erlotinib HCl (OSI-774) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2003
Actual Study Completion Date : October 2005

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 potential
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337883

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Barbara Klencke, M.D. Genentech, Inc.
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Responsible Party: Genentech, Inc. Identifier: NCT00337883    
Obsolete Identifiers: NCT00090883
Other Study ID Numbers: OSI2691g
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: February 2014
Keywords provided by Genentech, Inc.:
Glioblastoma Multiforme
Grade IV glioma
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action