S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

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)

Sponsors

Lead Sponsor: Southwest Oncology Group

Collaborator: National Cancer Institute (NCI)

Source Southwest Oncology Group
Brief Summary

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.

Detailed Description

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.

Overall Status Completed
Start Date January 2005
Completion Date February 2008
Primary Completion Date February 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall Survival 0 - 3 years
Secondary Outcome
Measure Time Frame
Progression-free Survival 0 - 3 years
Response 9 weeks - 3 years
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.
Enrollment 67
Condition
Intervention

Intervention Type: Drug

Intervention Name: gemcitabine

Description: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).

Arm Group Label: gemcitabine paclitaxel combination

Intervention Type: Drug

Intervention Name: paclitaxel

Description: 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Arm Group Label: gemcitabine paclitaxel combination

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Omer Kucuk, MD Principal Investigator Barbara Ann Karmanos Cancer Institute
Location
Facility:
Northeast Alabama Regional Medical Center | Anniston, Alabama, 36202, United States
Mobile Infirmary Medical Center | Mobile, Alabama, 36652-2144, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora, Colorado, 80045, United States
Veterans Affairs Medical Center - Denver | Denver, Colorado, 80220, United States
Montrose Memorial Hospital Cancer Center | Montrose, Colorado, 81401, United States
Exempla Lutheran Medical Center | Wheat Ridge, Colorado, 80033, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia, 31603, United States
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii, 96701, United States
Cancer Research Center of Hawaii | Honolula, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii, 96817, United States
St. Francis Medical Center | Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, 96826, United States
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois, 62002, United States
Veterans Affairs Medical Center - Hines | Hines, Illinois, 60141, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois, 60153, United States
Good Samaritan Regional Health Center | Mt. Vernon, Illinois, 62864, United States
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas, 66160-7357, United States
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas, 67068, United States
Southwest Medical Center | Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton | Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina | Salina, Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review | Wichita, Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas, 67214, United States
CCOP - Wichita | Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas, 67156, United States
Christus Schumpert Cancer Treatment Center | Shreveport, Louisiana, 71101, United States
Cancer Research Center at Boston Medical Center | Boston, Massachusetts, 02118, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109-0942, United States
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan, 49017, United States
Bay Regional Medical Center | Bay City, Michigan, 48708, United States
Mecosta County Medical Center | Big Rapids, Michigan, 49307, United States
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, 48201-1379, United States
CCOP - Grand Rapids | Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan, 49503, United States
Metro Health Hospital | Grand Rapids, Michigan, 49506, United States
Holland Community Hospital | Holland, Michigan, 49423, United States
Hackley Hospital | Muskegon, Michigan, 49442, United States
Munson Medical Center | Traverse City, Michigan, 49684, United States
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States
Saint Francis Medical Center | Cape Girardeau, Missouri, 63701, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri, 63701, United States
David C. Pratt Cancer Center at St. John's Mercy | Saint Louis, Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks | Springfield, Missouri, 65802, United States
St. John's Regional Health Center | Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri, 65807, United States
CCOP - St. Louis-Cape Girardeau | St. Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium | Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center | Billings, Montana, 59101, United States
St. Vincent Healthcare | Billings, Montana, 59101, United States
Billings Clinic Cancer Center | Billings, Montana, 59107-5100, United States
Deaconess Billings Clinic - Downtown | Billings, Montana, 59107-7000, United States
Bozeman Deaconess Hospital | Bozeman, Montana, 59715, United States
St. James Community Hospital | Butte, Montana, 59701, United States
Great Falls Clinic | Great Falls, Montana, 59405, United States
| Great Falls, Montana, 59405, United States
St. Peter's Hospital | Helena, Montana, 59601, United States
Glacier Oncology, PLLC | Kalispell, Montana, 59901, United States
Kalispell Medical Oncology | Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center | Kalispell, Montana, 59901, United States
Community Medical Center | Missoula, Montana, 59801, United States
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska, 68848-1990, United States
Adirondack Cancer Care - Glens Falls | Glens Falls, New York, 12801, United States
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina, 28233-3549, United States
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology | Goldsboro, North Carolina, 27534, United States
Rutherford Hospital | Rutherfordton, North Carolina, 28139, United States
Wilson Medical Center | Wilson, North Carolina, 27893-3428, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio, 44131, United States
Cleveland Clinic - Wooster | Wooster, Ohio, 44691, United States
Legacy Mount Hood Medical Center | Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital | Milwaukie, Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon, 97213-2967, United States
CCOP - Columbia River Oncology Program | Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center | Portland, Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon, 97227, United States
Legacy Meridian Park Hospital | Tualatin, Oregon, 97062, United States
AnMed Health Cancer Center | Anderson, South Carolina, 29621, United States
Roper St. Francis Cancer Center at Roper Hospital | Charleston, South Carolina, 29401, United States
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina, 29425, United States
CCOP - Upstate Carolina | Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina, 29303, United States
Medical City Dallas Hospital | Dallas, Texas, 75230, United States
Center for Cancer Medicine and Blood Disorders, PA | El Paso, Texas, 79902, United States
Brooke Army Medical Center | Fort Sam Houston, Texas, 78234, United States
Wilford Hall Medical Center | Lackland AFB, Texas, 78236, United States
UMC Southwest Cancer and Research Center | Lubbock, Texas, 79415-3364, United States
Danville Regional Medical Center | Danville, Virginia, 24541, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia, 24115, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk, Virginia, 23507, United States
St. Joseph Cancer Center | Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology | Bremerton, Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington, 98273, United States
Group Health Central Hospital | Seattle, Washington, 98104-1387, United States
Fred Hutchinson Cancer Research Center | Seattle, Washington, 98104, United States
Harborview Medical Center | Seattle, Washington, 98104, United States
Minor and James Medical, PLLC | Seattle, Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington, 98122-4307, United States
Polyclinic First Hill | Seattle, Washington, 98122, United States
University Cancer Center at University of Washington Medical Center | Seattle, Washington, 98195-6043, United States
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington, 98284, United States
Cancer Care Northwest - Spokane South | Spokane, Washington, 99202, United States
Southwest Washington Medical Center Cancer Center | Vancouver, Washington, 98668, United States
Wenatchee Valley Medical Center | Wenatchee, Washington, 98801-2028, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg, West Virginia, 26102, United States
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, 82801, United States
Location Countries

United States

Verification Date

August 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: gemcitabine paclitaxel combination

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov