At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed glioblastoma multiforme with progressive disease despite standard therapy (phase I)
- ✓Castrate metastatic prostate cancer with progressive disease despite standard therapy and testosterone <50 ng/dL (phase I and II)
- ✓Progressive disease demonstrated by imaging (≥25% increase in soft tissue masses or new lesions) or rising PSA (3 rising values ≥1 week apart or 2 values >1 month apart with ≥25% increase)
- ✓Age >18 years
- ✕Brain metastases
- ✕Active angina pectoris or myocardial infarction within past 6 months
- ✕Congestive heart failure or NYHA class III/IV cardiac disease
- ✕Other active malignancy except non-melanoma skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial to Assess the Tolerability of RAD 001 With Gefitinib in Patients With Glioblastoma Multiforme and Prostate Cancer and Efficacy in Patients With Castrate Metastatic Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating everolimus and gefitinib for Brain and Central Nervous System Tumors and Prostate Cancer. Completed, enrolled 61 participants across 2 sites in 2 countries.
Detailed Summary
RATIONALE: Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining everolimus with gefitinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with gefitinib and to see how well they work in treating patients with progressive glioblastoma multiforme or (progressive metastatic prostate cancer closed to accrual 10/19/06).