Head and Neck Cancer Clinical Trial
Official title:
Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating
patients with advanced squamous cell head and neck cancer that cannot be treated by surgery
or radiation therapy.
OBJECTIVES: I. Evaluate the response rate and toxicity of weekly cisplatin and gemcitabine
in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who
have received either no prior chemotherapy or no more than one prior chemotherapy regimen
for advanced disease.
OUTLINE: Patients are stratified according to prior chemotherapy status: chemotherapy naive
(no prior chemotherapy, or prior neoadjuvant or adjuvant chemotherapy at least 6 months
prior to recurrence, or prior biologic agents only) vs chemotherapy exposed (one prior
chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease and/or
prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence). Patients
receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest.
Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine.
Treatment repeats every 28 days for 2-6 courses, depending on response. Patients with
previously untreated metastatic disease may have treatment interrupted to receive radiation
therapy to locoregional disease sites. Patients may continue treatment beyond 6 courses at
the discretion of the physician. Patients are followed every 3 months.
PROJECTED ACCRUAL: This study will accrue approximately 36 patients.
;
Primary Purpose: Treatment
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