At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma (GS)
- ✓Diagnosis established by biopsy or resection ≤5 weeks prior to treatment
- ✓MRI or CT scan within 14 days of treatment (MRI preferred)
- ✓No prior cranial radiation therapy
- ✕History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of cervix) unless in complete remission off all therapy for ≥3 years
- ✕Active infection
- ✕Pregnant or breastfeeding
- ✕Recent thromboembolic disease (DVT/PE) within 3 weeks of enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma
In Brief
A Phase 2 clinical trial evaluating Tarceva, Temodar, and 1 other intervention for Glioblastoma Multiforme and Gliosarcoma. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no "placebo" drug.
Study Details
Timeline
Interventions
Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status
Temodar 200 mg/m\^2/day x 5 days every 28 days
Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.