Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT00003821|
Recruitment Status : Unknown
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 4, 2004
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: aminopterin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma|
|Study Start Date :||January 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003821
|United States, Missouri|
|Division of Gynecologic Oncology|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|East Carolina University School of Medicine|
|Greenville, North Carolina, United States, 27858-4354|
|United States, Ohio|
|Gynecologic Oncologists of NE Ohio|
|Akron, Ohio, United States, 44302|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|Texas Oncology, P.A.|
|Dallas, Texas, United States, 75246|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||David S. Miller, MD||Simmons Cancer Center|