Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer
The purpose of this study is to look at how well the combination of two chemotherapy drugs, pemetrexed (Alimta) and gemcitabine (Gemzar) work to treat your cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (SCCHN)|
- Response rate will be measured. [ Time Frame: after every 2 cycles of treatment ] [ Designated as safety issue: No ]
- Secondary objectives will be to measure the time to progression overall survival. [ Time Frame: after every 2 cycles ] [ Designated as safety issue: No ]
- Safety [ Time Frame: at least weekly ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
This research study is being done because we have not yet been able to find the best treatment for recurrent or advanced head and neck cancer (SCCHN). Pemetrexed and gemcitabine have helped fight against SCCHN when each was given by itself. This study is different from others because it tests these two drugs together, which has not been tried before in patients with SCCHN. We will see how well these drugs can work to help to control or shrink your cancer.
We also want to find out what effects (good and bad) gemcitabine and pemetrexed have on you and your head and neck cancer. We do not know if these drugs will help you. Your cancer might get better or it might get worse. It might not have any effect on your condition. We can use what we learn from this research study to help other people with the same cancer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394147
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator:||Ranee Mehra, MD||Fox Chase Cancer Center - Medical Oncology|