Study of Pemetrexed for Second-Line Pancreas Cancer
|ClinicalTrials.gov Identifier: NCT00864513|
Recruitment Status : Terminated (At interim analysis the study did not meet the response criteria to continue)
First Posted : March 18, 2009
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine.
In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Drug: pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine|
|Study Start Date :||October 2007|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
- Progression-free Survival [ Time Frame: 6 months after last patient enrolled ]Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.
- Objective Response [ Time Frame: Within two months of the completion of the last dose of chemotherapy ]Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0
- CA 19-9 Response [ Time Frame: Within two months of the last dose of chemotherapy ]CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.
- Number of Participants With Adverse Events [ Time Frame: 30 days after last dose of study drug ]Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864513
|United States, District of Columbia|
|Georgetown University Hospital/Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Jimmy J Hwang, M.D.||Georgetown University|