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Ixabepilone in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
First Received: April 9, 2002   Last Updated: July 23, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with 2 different dosing schedules of ixabepilone.
  • Compare the toxicity of these drug schedules in these patients.
  • Correlate survivin expression with therapeutic responsiveness to this drug in these patients.
  • Correlate changes in tumor vascular density and endothelial cell apoptosis with outcome in patients treated with this drug.

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.

  • Arm I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery or radiotherapy

    • No nasopharyngeal primaries
  • Measurable disease

    • If the only site of measurable disease is in a previously irradiated area, then patient must have documented disease progression or biopsy-proven residual carcinoma
    • Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiotherapy
  • Must have distant metastases or locoregional recurrence or persistent disease within a prior radiation portal

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.2 mg/dL OR
  • Creatinine clearance at least 50 mL/min
  • Calcium normal
  • No prior malignancy-associated hypercalcemia

Other:

  • No other prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater pre-existing peripheral neuropathy
  • No active infection
  • No greater than grade 1 or uncomplicated, non-recurrent grade 2 hypersensitivity reaction to castor oil, agents containing Cremophor EL, or paclitaxel
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • No more than 1 prior biologic therapy regimen

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for recurrent and/or metastatic SCCHN
  • No prior investigational taxane
  • Prior docetaxel or paclitaxel allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery:

  • Recovered from prior surgery

Other:

  • No concurrent treatment for a recent infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033618

  Hide Study Locations
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
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Barbara A. Burtness, MD Yale University
  More Information

Additional Information:
Publications:
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Ann Oncol. 2008 Feb 21; [Epub ahead of print]
Burtness B, Goldwasser MA, Axelrod R, et al.: A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. [Abstract] J Clin Oncol 24 (Suppl 18): A-5532, 288s, 2006.
Burtness B, Manola J, Argiris A, et al.: Randomized phase II study of BMS-247550 (NSC 710428) given daily X 5 days or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: E2301. [Abstract] European Journal of Cancer Supplements 4 (12): A-632, 190, 2006.

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009