Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies|
- Overall Response Rate [ Time Frame: Every two 28 day treatment cycles until subject no longer on treatment due to disease progression ]
Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Overall Response Rate (ORR)=PR+CR.
- Qualitative and Quantitative Toxicity [ Time Frame: Every two 28 day treatment cycles ]The most common toxicities were grades 1 or 2 fatigue and anemia .
|Study Start Date:||April 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment with Study Drugs
Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Drug: Oxaliplatin, Capecitabine
Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment.
The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266279
|United States, Kentucky|
|University of Louisville, James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Damian Laber, M.D.||University of Louisville, James Graham Brown Cancer Center|