Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

NCT00387894 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000492762UCSF-06102UCSF-H5941-28905-01GENENTECH-OSI3765s
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.

Conditions

Adult Brain Tumors

Keywords

adult glioblastoma; adult gliosarcoma; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

• Disease Response Measured Objectively by MRI of Brain

  Lack of disease progression indicates response to treatment

  Every 8 weeks or as indicated

Secondary Outcomes (1)

• Duration of Progress-free Survival (PFS)

  Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)

Study Arms (1)

erlotinib hydrochloride (Tarceva)

EXPERIMENTAL

During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

Drug: erlotinib hydrochloride

Interventions

erlotinib hydrochloride DRUG

Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

Also known as: Tarceva

erlotinib hydrochloride (Tarceva)

Eligibility Criteria

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

You may qualify if:

• 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 GS
• 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
• PATIENT CHARACTERISTICS:
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michael Prados: lead
• National Cancer Institute (NCI): collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated early for 2 reasons: 1. ongoing literature at the time confirming that the selection process was not likely to enrich for a patient population expected to benefit, and 2. Rapid disease progression in the first 6 patients.

Results Point of Contact

• Title: Michael Prados, MD
• Organization: University of California San Francisco

PradosM@neurosurg.ucsf.edu

415-353-7500

Study Officials

• Michael D. Prados, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 4, 2013
• Results First Posted: May 17, 2013

Record last verified: 2013-04

Locations

US (1)