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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
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Great Falls ClinicGreat Falls, Montana  59405
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Bay Regional Medical CenterBay City, Michigan  48708
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Adirondack Cancer Care - Glens FallsGlens Falls, New York  12801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
UMC Southwest Cancer and Research CenterLubbock, Texas  79415-3364
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Montrose Memorial Hospital Cancer CenterMontrose, Colorado  81401
Exempla Lutheran Medical CenterWheat Ridge, Colorado  80033
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
St. Francis Medical CenterHonolulu, Hawaii  96817
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
Christus Schumpert Cancer Treatment CenterShreveport, Louisiana  71101
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Center for Cancer Medicine and Blood Disorders, PAEl Paso, Texas  79902