S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
- Registration Number
- NCT00337129
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.
- Detailed Description
OBJECTIVES:
* Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.
* Estimate progression-free and overall survival probability in these patients.
* Evaluate the qualitative and quantitative toxicities of this treatment regimen.
OUTLINE: This is a multicenter study.
Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description eribulin mesylate eribulin mesylate eribulin mesylate
- Primary Outcome Measures
Name Time Method Response Probability (Confirmed Complete and Partial Responses) Every 6 weeks until progression of disease up to a maximum of 3 years after registration Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
- Secondary Outcome Measures
Name Time Method Overall Survival Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration. Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Participants With a Given Type of AE Every 3 weeks while on protocol therapy, up to 3 years. The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
Progression-Free Survival Every 6 weeks until progression of disease up to a maximum of 3 years after registration. Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
Trial Locations
- Locations (138)
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Providence Cancer Center at Holy Family Hospital
🇺🇸Spokane, Washington, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Broward General Medical Center Cancer Center
🇺🇸Fort Lauderdale, Florida, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Bay Area Hospital
🇺🇸Coos Bay, Oregon, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Salem Hospital Regional Cancer Care Services
🇺🇸Salem, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸Orlando, Florida, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Hematology Oncology Associates, PC
🇺🇸Albuquerque, New Mexico, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Adventist Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States