Neoadjuvant Cisplatin/Docetaxel (CDDP/TXT) and Chemoradiation for Head and Neck Cancer

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Treatments: Carboplatin; Cisplatin; Docetaxel

Criteria

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