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Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
This study has been completed.
Study NCT00021099   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
May 2001
 
 
 
Complete list of historical versions of study NCT00021099 on ClinicalTrials.gov Archive Site
 
 
 
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium

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.

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.

Phase II
Interventional
Treatment, Open Label
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
Drug: ixabepilone
 
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]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   South Africa
 
NCT00021099
 
CDR0000068747, ECOG-E3800
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP