19 Years and up
Accepting Healthy Volunteers?
- The patient has histologically proven primary or recurrent squamous cell carcinoma
arising in the oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx.
- The patient has stage III or IV disease.
- Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
- Age 19 years and above.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
- The patient has:
1. adequate hepatic function with bilirubin < upper limit of normal (ULN)
2. transaminases (SGOT and SGPT) may be up to 2.5 x ULN if alkaline phosphatase is <
ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN
3. adequate renal function with serum creatinine < 1.5 mg/dl (or estimated
creatinine clearance of > 50 mL/min)
4. normal serum calcium
5. adequate hematologic function as: defined by an absolute neutrophil count >
1500/ml, hemoglobin > 8.0 g/dl, and platelet count > 100,000/ml.
- The patient may have had a prior malignancy but must be three years from treatment.
- A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix
less then three years will be allowed.
- The patient must agree to use effective contraception if procreative potential exists,
and continue contraception for at least 6 months following completion of the study.
- Patient must sign informed consent.
- The patient has received radiation therapy previously to the head and neck.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Peripheral neuropathy > Grade 2.
- Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial
fibrillation, active hepatitis).
- Any underlying psychological condition that would prohibit the understanding and
rendering of informed consent.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80 must be excluded.