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
OBJECTIVES:
Primary
- 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.
Secondary
- To determine the effects of this regimen on progression-free survival and overall
survival.
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
toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
No
David S. Miller, MD
Study Chair
Simmons Cancer Center
Unspecified
CDR0000597154
NCT00691301
September 2008
Name | Location |
---|---|
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 |