A Trial for Patients With Advanced/Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00190983|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : August 24, 2009
Last Update Posted : November 20, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia Uterine Neoplasms Genital Neoplasms, Female||Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of Pemetrexed (Alimta) in the Treatment of Recurrent Carcinoma of the Cervix|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression.
- Tumor Response [ Time Frame: baseline to measured progressive disease (up to 5 years) ]Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
- Duration of Response [ Time Frame: time of initial response until documented tumor progression (up to 5 years) ]The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
- Progression-Free Survival [ Time Frame: baseline until documented tumor progression (up to 5 years) ]The period from study entry until disease progression, death or date of last contact.
- Overall Survival [ Time Frame: baseline until death from any cause (up to 5 years) ]Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the 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): NCT00190983
|United States, Pennsylvania|
|Gynecologic Oncology Group 215-854-0770|
|Philadelphia, Pennsylvania, United States|
|Study Chair:||David Miller, MD||Gynecologic Oncology Group|