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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033618 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: ixabepilone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase II Study Of BMS-247550 (NSC 710428) Given Daily X 5 Days Every 3 Weeks Or Weekly In Patients With Metastatic Or Recurrent Squamous Cell Cancer Of The Head And Neck |
| Study Start Date: | November 2002 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to prior taxane therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
In both arms, patients achieving complete response (CR) receive 2 additional courses past CR if a minimum of 6 courses have been administered.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 64-144 patients (16-36 per stratum) will be accrued for this study within 8-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery or radiotherapy
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5216 | |
| Veterans Affairs Medical Center - Palo Alto | |
| Palo Alto, California, United States, 94304-1290 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-3289 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| Veterans Affairs Medical Center - Gainesville | |
| Gainesville, Florida, United States, 32608-1197 | |
| Veterans Affairs Medical Center - Miami | |
| Miami, Florida, United States, 33125 | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Veterans Affairs Medical Center - Atlanta (Decatur) | |
| Decatur, Georgia, United States, 30033 | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615-7828 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Veterans Affairs Medical Center - Lakeside Chicago | |
| Chicago, Illinois, United States, 60611-4494 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| Veterans Affairs Medical Center - Wichita | |
| Wichita, Kansas, United States, 67218 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Cancer Center at Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417-2399 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Midlands Cancer Center at Midlands Community Hospital | |
| Papillion, Nebraska, United States, 68128-4157 | |
| Veterans Affairs Medical Center - Omaha | |
| Omaha, Nebraska, United States, 68105 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Veterans Affairs Medical Center - East Orange | |
| East Orange, New Jersey, United States, 07018 | |
| United States, New Mexico | |
| MBCCOP - University of New Mexico HSC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| MBCCOP-Our Lady of Mercy Cancer Center | |
| Bronx, New York, United States, 10466 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Veterans Affairs Medical Center - Brooklyn | |
| Brooklyn, New York, United States, 11209 | |
| Veterans Affairs Medical Center - New York | |
| New York, New York, United States, 10010 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43206 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623-3456 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Abramson Cancer Center at the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| CCOP - MainLine Health | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Hahnemann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Veterans Affairs Medical Center - Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus | |
| Nashville, Tennessee, United States, 37212-2637 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Wisconsin | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-0001 | |
| Veterans Affairs Medical Center - Madison | |
| Madison, Wisconsin, United States, 53705 | |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Westmead, New South Wales, Australia, 2145 | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Puerto Rico | |
| MBCCOP - San Juan | |
| San Juan, Puerto Rico, 00921-3201 | |
| San Juan City Hospital | |
| San Juan, Puerto Rico, 00936-7344 | |
| Veterans Affairs Medical Center - San Juan | |
| San Juan, Puerto Rico, 00927-5800 | |
| South Africa | |
| Pretoria Academic Hospital | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | Barbara A. Burtness, MD | Yale University |
More Information
| Study ID Numbers: | CDR0000069305, ECOG-E2301 |
| Study First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033618 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx |
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Epothilones |
Head and Neck Neoplasms Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |