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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
Not Enrolling
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)


- 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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- No concurrent biologic or immunotherapy for SCCHN

- No concurrent gene therapy for SCCHN


- 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

- No other concurrent chemotherapy for SCCHN

Endocrine therapy

- Not specified


- At least 28 days since prior radiotherapy and recovered

- No concurrent radiotherapy for SCCHN


- Not specified


- No other concurrent therapy for SCCHN

Type of Study:


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:


Principal Investigator

Omer Kucuk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




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



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Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
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Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
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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
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Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
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Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
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Olympic Hematology and Oncology Bremerton, Washington  98310
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Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
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Veterans Affairs Medical Center - Hines Hines, Illinois  60141
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Bay Regional Medical Center Bay City, Michigan  48708
Mecosta County Medical Center Big Rapids, Michigan  49307
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Adirondack Cancer Care - Glens Falls Glens Falls, New York  12801
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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
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Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
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Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
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Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
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