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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.

Tracking Information
First Submitted Date  ICMJE June 15, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Efficacy of Tarceva in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: Erlotinib HCl (OSI-774)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†15,¬†2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00337883
Other Study ID Numbers  ICMJE OSI2691g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Barbara Klencke, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP