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Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme


OBJECTIVES:

- Determine the response rate of patients with recurrent or progressive glioblastoma
multiforme treated with erlotinib.

- Determine the progression-free and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme

- Radiographic evidence of recurrence or progression

- Biopsies to confirm tumor recurrence allowed if a sufficent percentage of
cases are confirmed to be recurrent tumor

- Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy
regimen

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 2 times normal

- Alkaline phosphatase no greater than 2 times normal

- ALT no greater than 3 times normal

Renal

- BUN no greater than 1.5 times normal OR

- Creatinine no greater than 1.5 times normal

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No medical condition that would interfere with oral administration of erlotinib

- No other medical or psychiatric illness that would preclude study therapy

- No active infection

- No other malignancy within the past 3 years except surgically cured carcinoma in situ
of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy for brain cancer

- No concurrent biologic therapy for brain cancer

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent chemotherapy for brain cancer

Endocrine therapy

- Concurrent glucocorticosteroids allowed

- No concurrent hormonal therapy for brain cancer

Radiotherapy

- See Disease Characteristics

Surgery

- Not specified

Other

- No prior epidermal growth factor receptor (EGFR) inhibitor

- No concurrent EGFR inhibitor

- No other concurrent antineoplastic therapy

- No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs
such as the following:

- Gabapentin

- Lamotrigine

- Divalproex

- Felbamate

- Levetiracetam

- Tiagabine

- Topiramate

- Zonisamide

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Michael A. Vogelbaum, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

Unspecified

Study ID:

CDR0000270723

NCT ID:

NCT00054496

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195