S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
NCT ID: NCT00100789
Last Updated: 2012-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2005-01-31
2008-02-29
Brief Summary
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PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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gemcitabine paclitaxel combination
gemcitabine
3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
paclitaxel
150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
Interventions
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gemcitabine
3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
paclitaxel
150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine
Other Intervention Names
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Eligibility Criteria
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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
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Omer Kucuk, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
Valdosta, Georgia, United States
Cancer Research Center of Hawaii
Honolula, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 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
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 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
Christus Schumpert Cancer Treatment Center
Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Bay Regional Medical Center
Bay City, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, 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
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
Metro Health Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 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
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, United States
Cleveland Clinic - Wooster
Wooster, Ohio, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, 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
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Center for Cancer Medicine and Blood Disorders, PA
El Paso, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States
Danville Regional Medical Center
Danville, Virginia, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
Martinsville, Virginia, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical, PLLC
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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S0329
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000407644
Identifier Type: -
Identifier Source: org_study_id