Spots Global Cancer Trial Database for Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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Trial Identification
Brief Title: Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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
Study ID: NCT00691301
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, United States
University of Mississippi Cancer Clinic, Jackson, Mississippi, United States
Women's Cancer Center - La Canada, Las Vegas, Nevada, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Cancer Care Associates - Saint Francis Campus, Tulsa, Oklahoma, United States
Parkland Memorial Hospital, Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Lyndon B. Johnson General Hospital, Houston, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Carilion Gynecologic Oncology Associates, Roanoke, Virginia, United States
Contact Details
Name: David S. Miller, MD
Affiliation: Simmons Cancer Center
Role: STUDY_CHAIR
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