Head and Neck Cancer Clinical Trial
Official title:
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)
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
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate as determined by RECIST criteria (CR and PR) will be used to determine efficacy in terms of reduction of tumor size and control of disease | 12 Weeks, 1 Year | No |
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