Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving pemetrexed together with cisplatin and to see how well it works in treating patients with advanced, persistent, or recurrent cervical cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Frequency and duration of objective response [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Time Frame: every 21 days ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: every 21 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Pemetrexed and cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days
|Drug: cisplatin Drug: pemetrexed disodium|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691301
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Mississippi|
|University of Mississippi Cancer Clinic|
|Jackson, Mississippi, United States, 39216|
|United States, Nevada|
|Women's Cancer Center - La Canada|
|Las Vegas, Nevada, United States, 89169|
|United States, Ohio|
|MetroHealth Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Saint Francis Campus|
|Tulsa, Oklahoma, United States, 74136-1929|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Parkland Memorial Hospital|
|Dallas, Texas, United States, 75235|
|Lyndon B. Johnson General Hospital|
|Houston, Texas, United States, 77026-1967|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Carilion Gynecologic Oncology Associates|
|Roanoke, Virginia, United States, 24016|
|Study Chair:||David S. Miller, MD||Simmons Cancer Center|