Study of Pemetrexed, Cisplatin and Cetuximab in Head and Neck Cancer

• Research type

  Research Study

• Full title

  Protocol H3E-MC-S123 Phase 2 Study of Pemetrexed in Combination with Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

• IRAS ID

  28989

• Contact name

  Kevin Harrington

• Sponsor organisation

  Eli Lilly and Company Inc.

• Eudract number

  2009-011611-21

• ISRCTN Number

  N/A

• Research summary

  The most common risk factors for head and neck cancer (NHC) are tobacco and alcohol use. Occupational risk factors included nickel refining, woodworking and exposure to textile fibres. Additionally, DNA from certain viruses has also been identified in many of the cancer tissues. Worldwide, more than 500,000 new cases of squamous cell carcinoma of the head and neck are projected annually.Currently the early stages of the disease can be cured with surgery and/or radiotherapy. However, most patients present with an advanced form of the disease and even with newer strategies of treatment, such as chemo-radiotherapy with or without induction chemotherapy, the 5-year survival rate remains around 30%.This phase II study plans to examine HNC that's recurrent and not amenable to surgery or radiation or newly diagnosed distant metastatic disease. Approximately 65 patients will be enrolled into the study, with at least 52 patients completing the treatment phase. Patients will receive pemetrexed plus cisplatin plus cetuximab for up to 6 cycles (21 days in each cycle), followed by an optional maintenance phase of pemetrexed plus cetuximab until disease progression. Cetuximab will be administered as an initial dose of 400 mg/m2 intravenous (IV) infusion and the subsequent weekly will be 250 mg/m2 IV, followed by pemetrexed 500 mg/m2 IV and cisplatin 75 mg/m2 IV on Day 1 of each 21-day cycle.The primary objective is to estimate the progression-free survival for combination of pemetrexed plus cisplatin plus cetuximab followed by optional pemetrexed plus cetuximab maintenance therapy.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/75

• Date of REC Opinion

  29 Jan 2010

• REC opinion

  Further Information Favourable Opinion