RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally advanced head and neck cancer.
OBJECTIVES: Primary * 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 oxaliplatin. Secondary * 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 of disease. * 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 chemoradiotherapy. Blood samples are collected at baseline and periodically during study for biomarker and pharmacokinetic studies. Quality of life is assessed prior to each course of therapy and at 4-6 weeks after the last course. After completion of study treatment, patients are followed periodically for up to 3 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
Group I: 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. Group II: 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.
Group I: 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. Group II: 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.
Mitchell Memorial Cancer Center at Owensboro Medical Health System
Owensboro, Kentucky, United States
Purchase Cancer Group - Paducah
Paducah, Kentucky, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
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.
Time frame: at 8 weeks
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TREATMENT
Masking
NONE
Enrollment
42
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States