Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients
The purpose of this study is to determine 1-year survival of previously irradiated Head and Neck cancer (HNC) patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed concomitant pemetrexed, carboplatin and daily radiotherapy.
Head and Neck Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pemetrexed-Based Induction Chemotherapy Followed by Concomitant Chemoradiotherapy in Previously Irradiated Head and Neck Cancer Patients|
- Primary objective is to determine 1-year survival of previously irradiated Head/Neck Cancer patients with loco-regional recurrent disease treated with induction chemotherapy with pemetrexed and gemcitabine followed by concomitant pemetrexed, carboplat [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
4 doses of induction chemotherapy every 2weeks(Days 1, 15, 28, and 42), through an infusion for approximately 10 minutes.
Day 1,22, and 43through IV infusion over a period of 10 minutes
Day 1, 22 and 4 through IV infusion over a period of 1 hour.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172470
|United States, Illinois|
|The University of Chicago Medical Center|
|Chicago, Illinois, United States, 60653|
|Principal Investigator:||Ezra Cohen, MD||The University of Chicago Medical Center|