Study of Pemetrexed for Second-Line Pancreas Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Pemetrexed as Second-Line Treatment in Patients With Pancreatic Cancer Progressing Despite Therapy With Gemcitabine|
- Progression-free survival [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
- Objective response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 6 months after last patient enrolled ] [ Designated as safety issue: No ]
- CA 19-9 response [ Time Frame: end of study treatment ] [ Designated as safety issue: No ]
- Toxicities [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: 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|