Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030095
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-01-30
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 Trial Of 2-Methoxyestradiol 2ME2 NSC-659853 An Angiogenesis Inhibitor In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors
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 this drug
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
Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors
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 this drug
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
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 |
|---|---|---|---|
| NCI-01-C-0256 | None | None | None |
| NCI-3371 | None | None | None |
| NCI-CC-01-C-0256 | None | None | None |