Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
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.
|Head and Neck Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck|
|Study Start Date:||October 1997|
|Study Completion Date:||June 2002|
|Primary Completion Date:||February 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003264
|United States, New Jersey|
|Hunterdon Regional Cancer Center|
|Flemington, New Jersey, United States, 08822|
|Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County|
|Mount Holly, New Jersey, United States, 08060|
|Riverview Medical Center - Booker Cancer Center|
|Red Bank, New Jersey, United States, 07701|
|St. Francis Medical Center|
|Trenton, New Jersey, United States, 08629|
|United States, Pennsylvania|
|St. Luke's Network - Bethlehem|
|Bethlehem, Pennsylvania, United States, 18015|
|Delaware County Memorial Hospital|
|Drexel Hill, Pennsylvania, United States, 19026|
|Harrisburg Polyclinic Medical Center|
|Harrisburg, Pennsylvania, United States, 17101|
|Saint Mary Regional Center|
|Langhorne, Pennsylvania, United States, 19047|
|North Penn Hospital|
|Lansdale, Pennsylvania, United States, 19446-1200|
|Paoli Memorial Hospital|
|Paoli, Pennsylvania, United States, 19301-1792|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|Study Chair:||Corey J. Langer, MD||Fox Chase Cancer Center|