Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

David Peereboom

Status and phase

Completed

Phase 2

Conditions

CNS Tumor, Adult

Treatments

Drug: temozolomide

Radiation: radiation therapy

Drug: erlotinib hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00274833

CCF-6320 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE3304 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with temozolomide and erlotinib after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and erlotinib works in treating patients with newly diagnosed glioblastoma multiforme.

Full description

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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