s9902 docetaxel plus carboplatin in treating patients with metastatic or recurrent head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.

objectives: i. assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. ii. assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. iii. evaluate the toxicities of this regimen in this patient population. outline: patients receive docetaxel iv over 1 hour immediately followed by carboplatin iv over 30 minutes on day 1. courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death. projected accrual: a total of 62 patients will be accrued for this study over 18 months.

Eligibility criteria:
disease characteristics: histologically proven squamous cell carcinoma of the head and neck metastatic disease at diagnosis or persistent, metastatic or recurrent disease following surgery and/or radiotherapy no newly diagnosed nonmetastatic disease bidimensionally measurable disease demonstrated progressive disease if only measurable site is within a previous radiotherapy port patient characteristics: age: 18 and over performance status: swog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2 times upper limit of normal (uln) sgot or sgpt no greater than 1.5 times uln alkaline phosphatase no greater than 2.5 times uln renal: calcium no greater than upper limit of normal (uln) creatinine no greater than 1.5 times uln or creatinine clearance at least 60 ml/min other: not pregnant or nursing fertile patients must use effective contraception no other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or any adequately treated stage i or ii cancer that is currently in complete remission no neuropathy sensory greater than grade 1 no history of hypersensitivity reaction to polysorbate 80 prior concurrent therapy: biologic therapy: no concurrent biologic therapy chemotherapy: no prior carboplatin or cisplatin no prior chemotherapy for recurrent disease no other concurrent chemotherapy endocrine therapy: no concurrent hormonal therapy (except oral contraceptives or treatment for osteoporosis) radiotherapy: see disease characteristics at least 28 days since prior radiotherapy and recovered no concurrent radiotherapy surgery: see disease characteristics at least 28 days since prior surgery and recovered

Keywords: recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage iv squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage iv squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity