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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
Sponsors and Collaborators: Eastern Cooperative Oncology Group
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

  Show 37 Study Locations
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

Study placed in the following topic categories:
Urinary Tract Neoplasm
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Urethral Cancer
Kidney Diseases
Bladder Neoplasm
Kidney Cancer
Epothilone B
Cystocele
Epothilones
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Antimitotic Agents
Recurrence
Carcinoma
Urethral Neoplasms
Tubulin Modulators
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

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 September 11, 2009