Head and Neck Cancer Clinical Trial
Official title:
Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Verified date | July 2012 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 2011 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Hematology Oncology Associates, PC | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico |
United States | Harrington Cancer Center | Amarillo | Texas |
United States | American Fork Hospital | American Fork | Utah |
United States | Alaska Regional Hospital Cancer Center | Anchorage | Alaska |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic - Downtown | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana |
United States | Northern Rockies Radiation Oncology Center | Billings | Montana |
United States | St. Vincent Healthcare Cancer Care Services | Billings | Montana |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | Providence Saint Joseph Medical Center - Burbank | Burbank | California |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Sandra L. Maxwell Cancer Center | Cedar City | Utah |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Bay Area Hospital | Coos Bay | Oregon |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Veterans Affairs Medical Center - Dayton | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Broward General Medical Center Cancer Center | Fort Lauderdale | Florida |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Metro Health Hospital | Grand Rapids | Michigan |
United States | Great Falls Clinic - Main Facility | Great Falls | Montana |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | St. Peter's Hospital | Helena | Montana |
United States | Holland Community Hospital | Holland | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology at KRMC | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | U.T. Cancer Institute at University of Tennessee Medical Center | Knoxville | Tennessee |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Logan Regional Hospital | Logan | Utah |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Middletown Regional Hospital | Middletown | Ohio |
United States | Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Skagit Valley Hospital Cancer Care Center | Mt. Vernon | Washington |
United States | Cottonwood Hospital Medical Center | Murray | Utah |
United States | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah |
United States | Hackley Hospital | Muskegon | Michigan |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California |
United States | M.D. Anderson Cancer Center at Orlando | Orlando | Florida |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Adventist Medical Center | Portland | Oregon |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon |
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 | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Interlakes Oncology/Hematology PC | Rochester | New York |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Dixie Regional Medical Center - East Campus | Saint George | Utah |
United States | Salem Hospital Regional Cancer Care Services | Salem | Oregon |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas |
United States | Latter Day Saints Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
United States | New Mexico Cancer Care Associates | Santa Fe | New Mexico |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical, PLLC | Seattle | Washington |
United States | Polyclinic First Hill | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | Providence Cancer Center at Holy Family Hospital | Spokane | Washington |
United States | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta | Georgia |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Probability (Confirmed Complete and Partial Responses) | 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. | Every 6 weeks until progression of disease up to a maximum of 3 years after registration | No |
Secondary | Progression-Free Survival | 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. | Every 6 weeks until progression of disease up to a maximum of 3 years after registration. | No |
Secondary | Overall Survival | 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. | Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration. | No |
Secondary | Participants With a Given Type of AE | The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized. | Every 3 weeks while on protocol therapy, up to 3 years. | Yes |
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