Pemetrexed and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00691301|
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: cisplatin Drug: pemetrexed disodium||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2008|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Pemetrexed and cisplatin
Pemtrexed plus cisplatin on day 1 every 21 days
Cisplatin as an IV infusion at less than 1 mg/min over less than 4 hours at a dose of
Drug: pemetrexed disodium
- Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [ Time Frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression or study withdrawal; and at any other time if clinically indicated, up to 5 years. ]RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
- Frequency and Severity of Observed Adverse Effects [ Time Frame: every 21 days during study treatment and up to 30 days after the last cycle of treatment. ]All eligible and evaluable patients
- Progression-free Survival [ Time Frame: From enrollment onto the study until the onset of disease progression or death, up to 5 years ]Duration of progression-free survival in months.
- Duration of Overall Survival [ Time Frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, up to 5 years. ]Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Parkland Memorial Hospital|
|Dallas, Texas, United States, 75235|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|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|