Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- To evaluate the clinical response rate in patients with locally advanced squamous cell
carcinoma of the head and neck treated with neoadjuvant pemetrexed disodium and
- To evaluate the pathological complete response in patients who undergo surgical
resection or post-induction biopsy.
- To assess toxicity of therapy, including the assessment of quality of life, fatigue,
and head and neck cancer-related symptoms.
- To predict response and toxicities based on pharmacogenomics, genomics, and proteomics.
OUTLINE: This is a nonrandomized, open-label study. Patients are assigned to 1 of 2 groups
based on resectability of disease (resectable vs nonresectable).
- Group I (resectable disease): Patients receive pemetrexed disodium IV and oxaliplatin
IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If
patient progresses before receiving 4 courses of treatment, treatment will be
discontinued and patient will proceed to surgery.
After completion of pemetrexed disodium and oxaliplatin, patients undergo surgical resection
- Group II (nonresectable disease): Patients receive treatment as in group I. If patient
progresses before receiving 4 courses of treatment, treatment will be discontinued and
patient will proceed to concurrent chemoradiotherapy.
After completion of pemetrexed disodium and oxaliplatin, patients undergo concurrent
Blood samples are collected at baseline and periodically during study for biomarker and
Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last
After completion of study treatment, patients are followed periodically for up to 3 years.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Response to Treatment Measured by RECIST Criteria
RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
at 8 weeks
Jill Gilbert, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC HN 0582
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|MBCCOP - Meharry Medical College - Nashville||Nashville, Tennessee 37208-3599|
|West Tennessee Cancer Center at Jackson-Madison County General Hospital||Jackson, Tennessee 38301|
|Mitchell Memorial Cancer Center at Owensboro Medical Health System||Owensboro, Kentucky 42303|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Vanderbilt-Ingram Cancer Center at Franklin||Nashville, Tennessee 37064|
|Purchase Cancer Group - Paducah||Paducah, Kentucky 42001|