Head and Neck Cancer Clinical Trial
Official title:
Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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