Recruiting
Phase 2

Erlotinib

Sponsor:

The Cleveland Clinic

Code:

NCT00054496

Conditions

Brain and Central Nervous System Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

erlotinib hydrochloride

Study Details

Brief summary:

RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

Conditions

Brain and Central Nervous System Tumors

Study ID

NCT00054496

Start date

Aug, 2002

Status verified date

Dec, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

73 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

erlotinib hydrochloride

Primary outcome measure

  • Response rate [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Cleveland Clinic Taussig Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente

866-223-8100

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 10, 2014

Last verified

Dec, 2006

Keywords

  • adult glioblastoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2014-01-10.