Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
- Conditions
- Endometrial Cancer
- Registration Number
- NCT00003821
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory or recurrent endometrial cancer.
- Detailed Description
OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients.
OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- 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 (6)
Division of Gynecologic Oncology
🇺🇸Saint Louis, Missouri, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Gynecologic Oncologists of NE Ohio
🇺🇸Akron, Ohio, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Texas Oncology, P.A.
🇺🇸Dallas, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Division of Gynecologic Oncology🇺🇸Saint Louis, Missouri, United States