drugset / Trial / NCT00039494

Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors

NCT00039494 ↗

Phase 2 Completed 171 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2002-12
Primary completion
2007-07
Completion
—

Outcome

Met primary endpoint

paper By definition, the primary end point was successfully met with a median survival time of 15.3 months. PMID 18955445 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Background Temozolomide Small molecule 200 mg/m2 Oral