NCT00503997

Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer

Phase II Trial: Efficacy and Toxicity of Induction Pemetrexed (ALIMTA) and Oxaliplatin (ELOXATIN) in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	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.
DRUG	pemetrexed disodium	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.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-06-01
• Completion: 2010-06-01
• First posted: 2007-07-19
• Last updated: 2012-05-10
• Results posted: 2012-03-12

Locations

7 sites across 1 country: United States