Head and Neck Cancer Clinical Trial
Official title:
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)
Verified date | August 2012 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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 | AnMed Health Cancer Center | Anderson | South Carolina |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Northeast Alabama Regional Medical Center | Anniston | Alabama |
United States | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | Bay Regional Medical Center | Bay City | Michigan |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | CCOP - Montana Cancer Consortium | Billings | Montana |
United States | Deaconess Billings Clinic - Downtown | 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 | Cancer Research Center at Boston Medical Center | Boston | Massachusetts |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | St. James Community Hospital | Butte | Montana |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | Roper St. Francis Cancer Center at Roper Hospital | Charleston | South Carolina |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | Veterans Affairs Medical Center - Denver | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
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 | Center for Cancer Medicine and Blood Disorders, PA | El Paso | Texas |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri |
United States | Adirondack Cancer Care - Glens Falls | Glens Falls | New York |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Metro Health Hospital | Grand Rapids | Michigan |
United States | Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan |
United States | Great Falls Clinic | Great Falls | Montana |
United States | Legacy Mount Hood Medical Center | Gresham | Oregon |
United States | St. Peter's Hospital | Helena | Montana |
United States | Veterans Affairs Medical Center - Hines | Hines | Illinois |
United States | Holland Community Hospital | Holland | Michigan |
United States | Cancer Research Center of Hawaii | Honolula | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Lusitana | Honolulu | Hawaii |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | St. Francis Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | Community Oncology Group at Cleveland Clinic Cancer Center | Independence | Ohio |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Glacier Oncology, PLLC | Kalispell | Montana |
United States | Kalispell Medical Oncology | Kalispell | Montana |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Wilford Hall Medical Center | Lackland AFB | Texas |
United States | Southwest Medical Center | Liberal | Kansas |
United States | UMC Southwest Cancer and Research Center | Lubbock | Texas |
United States | Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville | Virginia |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
United States | Providence Milwaukie Hospital | Milwaukie | Oregon |
United States | Community Medical Center | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Mobile Infirmary Medical Center | Mobile | Alabama |
United States | Montrose Memorial Hospital Cancer Center | Montrose | Colorado |
United States | Good Samaritan Regional Health Center | Mt. Vernon | Illinois |
United States | Skagit Valley Hospital Cancer Care Center | Mt. Vernon | Washington |
United States | Hackley Hospital | Muskegon | Michigan |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | CCOP - Columbia River Oncology Program | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | 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 | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri |
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 | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Minor and James Medical, PLLC | Seattle | Washington |
United States | Polyclinic First Hill | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | 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-Wooley | Washington |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Christus Schumpert Cancer Treatment Center | Shreveport | Louisiana |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | CCOP - St. Louis-Cape Girardeau | St. Louis | Missouri |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Legacy Meridian Park Hospital | Tualatin | Oregon |
United States | Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta | Georgia |
United States | Southwest Washington Medical Center Cancer Center | Vancouver | Washington |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
United States | Exempla Lutheran Medical Center | Wheat Ridge | Colorado |
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 | Wilson Medical Center | Wilson | North Carolina |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Cleveland Clinic - Wooster | Wooster | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | 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. | 0 - 3 years | No |
Secondary | Progression-free Survival | Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. | 0 - 3 years | No |
Secondary | Response | Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. | 9 weeks - 3 years | No |
Secondary | Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment. | Yes |
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