Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck
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
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|St. Francis Medical Center||Trenton, New Jersey 08629|
|Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|St. Luke's Network - Bethlehem||Bethlehem, Pennsylvania 18015|
|Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County||Mount Holly, New Jersey 08060|
|Hunterdon Regional Cancer Center||Flemington, New Jersey 08822|
|Riverview Medical Center - Booker Cancer Center||Red Bank, New Jersey 07701|
|Harrisburg Polyclinic Medical Center||Harrisburg, Pennsylvania 17101|
|Saint Mary Regional Center||Langhorne, Pennsylvania 19047|
|North Penn Hospital||Lansdale, Pennsylvania 19446-1200|
|Paoli Memorial Hospital||Paoli, Pennsylvania 19301-1792|