A Limited Access Phase II Trial of Pemetrexed (Alimta, LY231514) (NSC #698037) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
- To estimate the antitumor activity of pemetrexed disodium and cisplatin with objective
tumor response (partial and complete response) in patients with advanced, persistent,
or recurrent carcinoma of the cervix.
- To determine the nature and degree of toxicity of this regimen in these patients.
- To determine the effects of this regimen on progression-free survival and overall
OUTLINE: This is a multicenter study. Patients are stratified according to prior cisplatin
therapy as a radiosensitizer (yes vs no).
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1-4 hours on
day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
David S. Miller, MD
Simmons Cancer Center
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Carilion Gynecologic Oncology Associates||Roanoke, Virginia 24014|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Parkland Memorial Hospital||Dallas, Texas 75235|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Women's Cancer Center - La Canada||Las Vegas, Nevada 89169|
|Lyndon B. Johnson General Hospital||Houston, Texas 77026-1967|