Oxaliplatin and Docetaxel Followed by Cetuximab for Head and Neck Cancer

Study Overview
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Brief Summary
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A study of Oxaliplatin and Docetaxel followed by Cetuximab for head and neck cancer patients to determine their effect on the control and reduction of tumor size

Detailed Description
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This is a non-randomized, open-label, phase II study to assess the effects of oxaliplatin and docetaxel followed by epidermal factor-antibody (EGFR-AB) cetuximab on patients with previously treated recurrent /metastatic squamous cell carcinoma of the head and neck. Head and neck tissue will also be tested to determine if the protein Epidermal Growth Factor Receptor is present in the cancer cells.

Official Title
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Phase II Trial Of Oxaliplatin With Docetaxel Followed By Epidermal Growth Factor Antibody (EGFR-AB) Cetuximab In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

Conditions
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Head and Neck Cancer, Carcinoma, Squamous

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Docetaxel
* Drug: Cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed recurrent SCCHN 18 years or older Tumor site accessible by biopsy Measurable disease Receiving no other therapy ECOG performance status 0-1 Adequate bone marrow, renal function and hepatic function Exclusion Criteria: Active infection or fever within 3 days of treatment Active CNS metastases Prior malignancy within 5 years Hypersensitivity to study drugs Chemotherapy within 30 days of treatment Concurrent investigational therapy within 30 days Radiotherapy of more than 25% of bone marrow Peripheral neuropathy of grade 2 or greater Pregnant or lactating patients History of allogeneic transplant Active or previously treated HIV or Hepatitis B or C Patients with a tracheostomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will be treated with oxaliplatin 130 MG/M2 IV over 2 hours on day 1 and docetaxel 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle. Cycles of treatment will be repeated every 3 weeks for a total of 4 cycles or until disease progression or intolerable toxicity. Patients who were treated with 4 cycles of oxaliplatin and docetaxel and had a response or stable disease will be treated with cetuximab at 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks, or until disease progression or intolerable toxicity. | Drug: Oxaliplatin<br>* 130 MG/M2 IV over 2 hours on day 1 of 21 day cycle over a period of 4 cycles<br>* Other names: Eloxatin;Drug: Docetaxel<br>* 60 MG/M2 IV over 1 hour on day 1 of a 21 day cycle for a period of 4 cycles<br>* Other names: Taxotere;Drug: Cetuximab<br>* 400 MG/M2 on week 1 then 250 MG/M2 weekly for a total of 12 weeks<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Measured by Response Rate in Participants | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (NR/SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started; Progressive Disease (PD), A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | 12 Weeks, 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, head and neck cancer, squamous cell cancer