A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix
OBJECTIVES:
- Determine the antitumor activity of pemetrexed disodium in patients with recurrent
carcinoma of the cervix 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 22-60 patients will be accrued for this study within 1-2
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity
No
David S. Miller, MD
Study Chair
Simmons Cancer Center
United States: Federal Government
CDR0000372923
NCT00087113
August 2004
Name | Location |
---|---|
CCOP - Kansas City | Kansas City, Missouri 64131 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Doctors Medical Center | Modesto, California 95350 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Women's Cancer Center - Las Vegas | Las Vegas, Nevada 89102 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Williamette Gynecologic Oncology P.C. | Salem, Oregon 97301 |