A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Endometrial Carcinoma
OBJECTIVES:
- Determine the antitumor activity of pemetrexed disodium in patients with persistent or
recurrent endometrial adenocarcinoma that failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed
disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12)
intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study within 1-3.4
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity
No
David S. Miller, MD
Study Chair
Simmons Cancer Center
United States: Federal Government
CDR0000372921
NCT00087100
May 2006
Name | Location |
---|---|
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Alamance Cancer Center at Alamance Regional Medical Center | Burlington, North Carolina 27216 |