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A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
CNS Tumor, Adult

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Trial Information

A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme


OBJECTIVES:

- Determine the progression-free survival and overall survival of patients with newly
diagnosed glioblastoma multiforme treated with adjuvant radiotherapy, temozolomide, and
erlotinib hydrochloride.

- Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized study.

Patients receive oral temozolomide once daily on days 1-42 and undergo concurrent
radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Four weeks after
completion of radiotherapy and temozolomide, patients receive oral temozolomide once daily
on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity. Patients also receive oral
erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven glioblastoma multiforme

- Newly diagnosed disease

- Has undergone diagnostic biopsy or surgical resection within the past 28 days

PATIENT CHARACTERISTICS:

- ECOG 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 9 g/L

- Serum creatinine and total serum bilirubin < 1.5 times upper limit of normal (ULN)

- AST or ALT < 2.5 times ULN

- Alkaline phosphatase < 2.5 times ULN

- No other severe underlying disease (including HIV or chronic hepatitis B or C
infection)

- Fertile patients must use effective contraception

- Not pregnant or nursing

- No medical condition that could interfere with the oral administration of
temozolomide or erlotinib hydrochloride

- No other malignancy within the past 3 years with the exception of surgically cured
carcinoma in situ of the cervix, nonmelanoma skin cancer, or adequately treated stage
I or II cancer from which the patient is in complete remission

- No active infection

- No other condition that would preclude ability of the patient to be followed closely
at the Cleveland Clinic

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy or chemotherapy for this cancer

- No prior cranial radiotherapy

- No concurrent enzyme-inducing anti-epileptic drugs

- No prior temozolomide or erlotinib hydrochloride

- No other concurrent antineoplastic therapy

- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) during chemotherapy

- No concurrent electron, particle, or implant boost radiotherapy

- No concurrent radiosurgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

at 6 months

Safety Issue:

No

Principal Investigator

David M. Peereboom, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE3304

NCT ID:

NCT00274833

Start Date:

October 2005

Completion Date:

September 2012

Related Keywords:

  • CNS Tumor, Adult
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Central Nervous System Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195