A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors
- Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced
- Determine the side effect profile of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the changes in positron-emission tomography scans of patients treated with
- Determine the changes in apotosis in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of
evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed at day 30.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
William Dahut, MD
NCI - Medical Oncology Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|