2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00030095
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
NCI - Center for Cancer Research
🇺🇸Bethesda, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States