S0618 E7389 in Treating Patients With Metastatic or Recurrent 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 metastatic squamous neck cancer with occult primary squamous cell carcinoma, recurrent metastatic squamous neck cancer with occult primary, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, untreated metastatic squamous neck cancer with occult primary, salivary gland squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN) Disease is either metastatic at diagnosis or has persisted, metastasized, or recurred after definitive surgery and/or radiotherapy Not amenable to surgical resection for salvage therapy No newly diagnosed nonmetastatic disease No salivary or nasopharyngeal primary disease Patients who have failed primary surgery alone, and who have disease that is salvageable by radiation or chemoradiation, are not eligible Measurable disease Measurable disease within a previous radiotherapy port must demonstrate clearly progressive disease No active or prior CNS metastasis PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT and SGPT ≤ 2 times ULN Creatinine ≤ 2 times ULN Not pregnant or nursing Fertile patients must use effective contraception No known HIV positivity No prior malignancies except for the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer currently in complete remission Any other cancer for which the patient has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy for recurrent or newly diagnosed metastatic disease At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy No more than 1 prior induction or adjuvant regimen (may have included a taxane) More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor inhibitors and vascular endothelial growth factor inhibitors) More than 28 days since prior radiotherapy and recovered More than 28 days since prior surgery and recovered No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic therapy, or gene therapy) for SCCHN No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent prophylactic colony-stimulating factors during course 1
Sites / Locations
- Alaska Regional Hospital Cancer Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Providence Saint Joseph Medical Center - Burbank
- City of Hope Comprehensive Cancer Center
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- Broward General Medical Center Cancer Center
- M.D. Anderson Cancer Center at Orlando
- Northeast Georgia Medical Center
- Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- 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
- Lucille P. Markey Cancer Center at University of Kentucky
- Boston University Cancer Research Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Metro Health Hospital
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Holland Community Hospital
- Foote Memorial Hospital
- Sparrow Regional Cancer Center
- Hackley Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Munson Medical Center
- St. John Macomb Hospital
- University of Mississippi Cancer Clinic
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Great Falls Clinic - Main Facility
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Hematology Oncology Associates, PC
- Veterans Affairs Medical Center - Albuquerque
- University of New Mexico Cancer Center
- New Mexico Cancer Care Associates
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Wayne Memorial Hospital, Incorporated
- Rutherford Hospital
- McDowell Cancer Center at Akron General Medical Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma University Cancer Institute
- Bay Area Hospital
- 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
- Adventist Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- AnMed Cancer Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- U.T. Cancer Institute at University of Tennessee Medical Center
- Harrington Cancer Center
- Medical City Dallas Hospital
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Latter Day Saints Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Danville Regional Medical Center
- Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Columbia Basin Hematology
- Skagit Valley Hospital Cancer Care Center
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- Southwest Washington Medical Center Cancer Center
- Wenatchee Valley Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
eribulin mesylate
eribulin mesylate