Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer

Study Overview
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Brief Summary
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Patient receiving oxaliplatin and docetaxel will have longer progression free survival than those patients receiving standard care.

Detailed Description
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Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.

Official Title
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Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

Conditions
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Neoplasms, Head and Neck Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin and Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed metastatic or locoregionally recurrent SCCHN deemed incurable by local therapy Measureable disease No prior use of palliative chemo after the SCCHN is deemed incurable by local therapy No prior treatment with oxaliplatin or docetaxel 18 years of age or older ECOG Performance status 0-1 ANC 1,500/mcl or greater Adequate renal function Adequate liver function Recovered from acute and late effects of any prior treatment with a minimum of 4 weeks from the last session to enrollment in the study Patient or their legal representative must be able to read, understand, and provide informed consent Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication Exclusion Criteria: Patients with an active documented infection or with a fever (38.5 degrees celsius or higher) within 3 days of the first scheduled dose of study treatment Patients with active CNS metastases Hypercalcemia related to SCCHN History of prior malignancy with the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia or localized prostate cancer Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel or to other drugs formulated with polysorbate 90 Patients receiving concurrent investigational therapy or investigational therapy less than 30 days from first scheduled dose of study therapy Peripheral neuropathy grade 2 or higher Any medical condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results History of allogeneic transplant Known HIV or Hepatitis B or C (active, previously treated or both)

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This is a single arm trial. | Drug: Oxaliplatin and Docetaxel<br>* Chemotherapy Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as determined by RECIST criteria every 6 weeks. |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity and Quality of Life assessments every 3 weeks. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Disease, Metastatic Disease, Squamous Cell Carcinoma, Multicenter, Phase II