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

NCT00337883 | Completed Phase 2

• 1 other identifier: OSI2691g
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma

Keywords

Glioblastoma Multiforme; glioma; Grade IV glioma

Interventions

Erlotinib HCl (OSI-774) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Barbara Klencke, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: July 1, 2003
• Study Completion: October 1, 2005
• Last Updated: March 4, 2014

Record last verified: 2014-02