Official Title: A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Detailed Description: PRIMARY OBJECTIVES
I Determine the optimal biologic dose andor maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors
II Determine the qualitative and quantitative toxic effects of this drug in these patients
III Determine the pharmacokinetics and metabolism of this drug in these patients
IV Determine the biologic changes within the tumor of these patients when treated with this drug
V Correlate the pharmacokinetics and toxicity of this drug in these patients VI Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug
VII Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug
OUTLINE This is a dose-escalation study
Patients receive oral 2-methoxyestradiol 2-ME once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 2-ME 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 Additional patients are treated at the MTD
Patients are followed for 3 months
PROJECTED ACCRUAL A total of 42-60 patients will be accrued for this study within 19 months