A Phase 2 interventional study of erlotinib hydrochloride and 3-dimensional conformal radiation therapy in Adult Giant Cell Glioblastoma, Adult Glioblastoma and Adult Gliosarcoma, sponsored by National Cancer Institute (NCI). Completed at 139 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This pilot phase II trial is studying the side effects and best dose of erlotinib when given with temozolomide and radiation therapy and to see how well they work in treating patients with glioblastoma multiforme or other brain tumors. Radiation therapy uses high-energy x-rays to damage tumor cells. Erlotinib may interfere with the growth of tumor cells, slow the growth of the tumor, and make the tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and temozolomide with radiation therapy may kill more tumor cells.
PILOT STUDY OBJECTIVES:
I. Determine the maximum tolerated dose of erlotinib administered with temozolomide and radiotherapy in patients with glioblastoma multiforme or other grade 4 brain tumors who are currently on enzyme-inducing anticonvulsant (EIAC) therapy vs no EIAC therapy.
II. Determine the safety and tolerability of this regimen in these patients. III. Determine the toxic effects of this regimen in these patients. IV. Determine the efficacy of this regimen, in terms of 1-year survival, in these patients.
PHASE II OBJECTIVES:
I. Determine the response rate and time to progression in patients treated with this regimen.
II. Determine the 6-month progression-free survival of patients treated with this regimen.
III. Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation pilot study of erlotinib followed by a phase II study. Patients are stratified according to concurrent enzyme-inducing anticonvulsant drug use (yes vs no).
PILOT STUDY: Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Once the MTD of erlotinib is determined, additional patients are treated with erlotinib at the MTD, temozolomide, and radiotherapy as above.
Patients are followed every 3 months for 5 years and then annually for 10 years.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 171 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Inclusion Criteria:
Histologically confirmed diagnosis of 1 of the following:
Patients receive oral erlotinib once daily. After 1 week of erlotinib alone, patients also receive oral temozolomide once daily for 6 weeks and undergo concurrent radiotherapy 5 days a week for 6 weeks. After completion of radiotherapy, patients continue to receive erlotinib once daily alone in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of radiotherapy, patients also receive oral temozolomide once daily for 5 days. Temozolomide treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: erlotinib hydrochloride · Radiation: 3-dimensional conformal radiation therapy · Drug: temozolomide
Given orally
Also known as: CP-358,774, erlotinib, OSI-774
Also known as: 3D conformal radiation therapy, 3D-CRT
Given orally
Also known as: SCH 52365, Temodal, Temodar, TMZ
Survival
Time frame: At 52 weeks
Overall survival distribution
The overall survival distribution will be estimated using the method of Kaplan-Meier. The success probability, i.e., 12-month survival percentage, will be estimated as the number of evaluable patients still alive at 366 days divided by the total number of evaluable patients followed for at least 366 days.
Time frame: From start of study therapy to death due to any cause, up to 15 years
Time-to-disease progression
The time-to-progression distribution will be estimated using the Kaplan-Meier method.
Time frame: From start of study therapy to documentation of disease progression, up to 15 years
Maximum toxicity grade, assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Frequency tables will be reviewed to determine toxicity patterns.
Time frame: Up to 15 years
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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)