Head and Neck Neoplasms Clinical Trial
Official title:
A Pilot Study to Evaluate Response to Neoadjuvant Chemotherapy With Cisplatin and Docetaxel Followed by Chemoradiation Therapy With Carboplatin in Stage IV Non-metastatic Head and Neck Cancer
The purpose of this study is to evaluate the effectiveness and safety of neoadjuvant chemotherapy (chemotherapy given before radiotherapy) using cisplatin and docetaxel, followed by carboplatin given at the same time as radiotherapy in the treatment of locally advanced head and neck cancer.
Status | Recruiting |
Enrollment | 37 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx - Measurable or evaluable disease - No distant metastases - Tumor should be surgically unresectable for cure or resection is considered inadvisable - Age > 18 years - ECOG performance status 0, 1 or 2 - Life expectancy > 2 months - Patients must have adequate organ and marrow function as defined below: - Leukocytes > 3,000/mm3 - Absolute neutrophil count > 1,500/mm3 - Platelets > 100,000/mm3 - Hemoglobin > 10.0g/dL - Total Bilirubin <= institutional upper limit of normal - Aspartate aminotransferase < 2.5 X institutional upper limit of normal - Alanine aminotransferase < 2.5 X institutional upper limit of normal - Alkaline phosphatase < 2.5 X institutional upper limit of normal - Creatinine <= institutional upper limit of normal OR creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine > institutional upper limit of normal - Signed informed consent - Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment Exclusion Criteria: - Previous chemotherapy for this malignancy - Previous radiotherapy to head and neck region - Other malignancy within last 5 years except for non-melanoma skin cancer - Uncontrolled intercurrent illness that would prevent delivery of protocol therapy - Peripheral neuropathy > Grade 2 - Hypercalcemia - Patient is pregnant or lactating |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mountainview Medical Center | Berlin | Vermont |
United States | Fletcher Allen Health Care | Burlington | Vermont |
United States | Vermont Center for Cancer Medicine | Colchester | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer | 6 months after initiation of therapy | No | |
Secondary | Response rate to neoadjuvant chemotherapy with docetaxel/cisplatin in locally advanced squamous head and neck cancer | 3 months after initiation of therapy | No | |
Secondary | Response rate to chemoradiotherapy in locally advanced squamous head and neck cancer | 6 months after initiation of therapy | No | |
Secondary | Toxicity of neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer | Every 3 weeks for 6 months (during therapy) | Yes | |
Secondary | Progression free survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer | Every 6 months | No | |
Secondary | Overall survival after neoadjuvant chemotherapy with docetaxel/cisplatin, followed by chemoradiotherapy in locally advanced squamous head and neck cancer | Every 6 months | No |
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