Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT00274833
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00274833
Study Brief:
Protocol Section:
NCT00274833