Viewing Study NCT00028821



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00028821
Status: COMPLETED
Last Update Posted: 2013-01-16
First Post: 2002-01-04

Brief Title: 2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000069137 REGISTRY PDQ Physician Data Query httpsreporternihgovquickSearchU01CA069912
MC0017 None None None
U01CA069912 NIH None None