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Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Probability (Confirmed Complete and Partial Responses)

Outcome Description:

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.

Outcome Time Frame:

Every 6 weeks until progression of disease up to a maximum of 3 years after registration

Safety Issue:

No

Principal Investigator

Susanne M. Arnold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000481530

NCT ID:

NCT00337129

Start Date:

May 2006

Completion Date:

January 2010

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Harrington Cancer Center Amarillo, Texas  79106
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Columbia River Oncology Program Portland, Oregon  97225
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
City of Hope Comprehensive Cancer Center Duarte, California  91010
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Latter Day Saints Hospital Salt Lake City, Utah  84143
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange, California  92868
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Mecosta County Medical Center Big Rapids, Michigan  49307
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Providence Cancer Center at Holy Family Hospital Spokane, Washington  99207
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Northeast Georgia Medical Center Gainesville, Georgia  30501
Pearlman Comprehensive Cancer Center at South Georgia Medical Center Valdosta, Georgia  31603
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Adventist Medical Center Portland, Oregon  97216
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
U.T. Cancer Institute at University of Tennessee Medical Center Knoxville, Tennessee  37920-2911
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Bay Area Hospital Coos Bay, Oregon  97420
AnMed Cancer Center Anderson, South Carolina  29621
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Martinsville, Virginia  24115