A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
A Phase II Study of Biweekly Gemcitabine and Paclitaxel (GEMTAX) Combination in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
OBJECTIVES:
- Determine overall and progression-free survival probability in patients with
persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck
treated with gemcitabine and paclitaxel.
- Determine the confirmed and unconfirmed response (partial and complete) probability in
patients with measurable disease treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and
15. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
Patients are followed every 8 weeks until disease progression, every 6 month for 2 years,
and then annually for 1 year.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13
months.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome Time Frame:
0 - 3 years
Safety Issue:
No
Principal Investigator
Omer Kucuk, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000407644
NCT ID:
NCT00100789
Start Date:
January 2005
Completion Date:
February 2008
Related Keywords:
- Head and Neck Cancer
- Recurrent
- stage IV
- squamous cell carcinoma
- hypopharynx
- larynx
- lip
- oral cavity
- nasopharynx
- oropharynx
- paranasal
- nasal cavity
- metastatic
- neck cancer
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| 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 |
| Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
| Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
| 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 |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
| David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| 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 |
| 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 |
| North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Veterans Affairs Medical Center - Hines | Hines, Illinois 60141 |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Bay Regional Medical Center | Bay City, Michigan 48708 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
| Adirondack Cancer Care - Glens Falls | Glens Falls, New York 12801 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| 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 |
| UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
| Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
| Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
| 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 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia 26102 |
| St. Francis Medical Center | Honolulu, Hawaii 96817 |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| AnMed Health Cancer Center | Anderson, South Carolina 29621 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
| Great Falls, Montana 59405 | |
| Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina 29401 |
| Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
| OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
| OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
| Christus Schumpert Cancer Treatment Center | Shreveport, Louisiana 71101 |
| Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
| Center for Cancer Medicine and Blood Disorders, PA | El Paso, Texas 79902 |
