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Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
This study has been completed.
First Received: July 11, 2001   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: NCT00021099
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: ixabepilone
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium

Resource links provided by NLM:


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

Study Start Date: May 2001
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.
  • Assess the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 12-19 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (renal pelvis, ureter, bladder, or urethra)

    • Mixed histology carcinoma with a TCC component allowed
  • Progressive regional disease OR
  • Metastatic disease
  • Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting

    • May have included taxane-based therapy
  • Measurable disease outside prior irradiation field
  • Previously resected and irradiated CNS metastases with evidence of stable disease allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte 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 no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
  • No uncontrolled congestive heart failure
  • No ventricular dysrhythmia

Other:

  • No active unresolved infection requiring parenteral antibiotics within the past week
  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior systemic biologic response modifier therapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior major surgery and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021099

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Colorado
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Medical Center of Aurora - South Campus
Aurora, Colorado, United States, 80012-0000
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers - Denver Rose
Denver, Colorado, United States, 80220
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, United States, 80221
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Joseph Hospital
Denver, Colorado, United States, 80218-1191
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
Swedish Medical Center
Englewood, Colorado, United States, 80112
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Albert Einstein Cancer Center
Bronx, New York, United States, 10461
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
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, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
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
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
  More Information

Additional Information:
Publications:
Dreicer R, Li S, Manola J, Haas NB, Roth BJ, Wilding G. Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800) : a trial of the eastern cooperative oncology group. Cancer. 2007 Jun 26; [Epub ahead of print]
Dreicer R, Li S, Manola J, et al.: Phase II trial of epothilone B analogue BMS-247550 in advanced carcinoma of the urothelium (E3800): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 24 (Suppl 18): A-4543, 2006.

Study ID Numbers: CDR0000068747, ECOG-E3800
Study First Received: July 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00021099     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
recurrent urethral cancer
anterior urethral cancer
posterior urethral cancer
urethral cancer associated with invasive bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Kidney Diseases
Neoplasms by Histologic Type
Epothilones
Urinary Bladder Diseases
Mitosis Modulators
Urinary Bladder Neoplasms
Antimitotic Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Urethral Neoplasms
Tubulin Modulators
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009