S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Recurrent, stage IV, squamous cell carcinoma, hypopharynx, larynx, lip, oral cavity, nasopharynx, oropharynx, paranasal, nasal cavity, metastatic, neck cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) Recurrent, persistent, or newly diagnosed metastatic disease Measurable or non-measurable disease No active or prior CNS metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No serious organ dysfunction No serious comorbid conditions that would preclude study treatment No history of hypersensitivity reaction to products containing polysorbate 80 No active infection requiring systemic antibiotic therapy No symptomatic sensory neuropathy ≥ grade 2 No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic or immunotherapy for SCCHN No concurrent gene therapy for SCCHN Chemotherapy No prior chemotherapy for recurrent or newly diagnosed metastatic disease At least 6 months since prior induction or adjuvant chemotherapy No more than 1 prior induction or adjuvant regimen No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy No other concurrent chemotherapy for SCCHN Endocrine therapy Not specified Radiotherapy At least 28 days since prior radiotherapy and recovered No concurrent radiotherapy for SCCHN Surgery Not specified Other No other concurrent therapy for SCCHN
Sites / Locations
- Northeast Alabama Regional Medical Center
- Mobile Infirmary Medical Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Veterans Affairs Medical Center - Denver
- Montrose Memorial Hospital Cancer Center
- Exempla Lutheran Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- OnCare Hawaii, Incorporated - Kuakini
- St. Francis Medical Center
- Kapiolani Medical Center for Women and Children
- Saint Anthony's Hospital at Saint Anthony's Health Center
- Veterans Affairs Medical Center - Hines
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Christus Schumpert Cancer Treatment Center
- Cancer Research Center at Boston Medical Center
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Barbara Ann Karmanos Cancer Institute
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Holland Community Hospital
- Hackley Hospital
- Munson Medical Center
- University of Mississippi Medical Center
- Saint Francis Medical Center
- Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - St. Louis-Cape Girardeau
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Adirondack Cancer Care - Glens Falls
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- Cleveland Clinic Taussig Cancer Center
- Community Oncology Group at Cleveland Clinic Cancer Center
- Cleveland Clinic - Wooster
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Legacy Meridian Park Hospital
- AnMed Health Cancer Center
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Medical City Dallas Hospital
- Center for Cancer Medicine and Blood Disorders, PA
- Brooke Army Medical Center
- Wilford Hall Medical Center
- UMC Southwest Cancer and Research Center
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- Sentara Cancer Institute at Sentara Norfolk General Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Group Health Central Hospital
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
gemcitabine paclitaxel combination