Status:
COMPLETED
Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
David Peereboom
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
CNS Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: * Determine the progression-free survival and overall survival of patients with newly diagnosed glioblastoma multiforme treated with adjuvant radiotherapy, temozolomide, and erlotinib hyd...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00274833
Start Date
October 1 2005
End Date
September 1 2012
Last Update
December 6 2012
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195