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Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021099
First received: July 11, 2001
Last updated: January 23, 2013
Last verified: January 2013

July 11, 2001
January 23, 2013
June 2001
August 2007   (final data collection date for primary outcome measure)
The proportion of patients with clinical response measured using RECIST criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00021099 on ClinicalTrials.gov Archive Site
Toxicity graded using the NCI CTC version 2.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.

II. 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Distal Urethral Cancer
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Proximal Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urethral Cancer Associated With Invasive Bladder Cancer
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: ixabepilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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
  • Performance status - ECOG 0-2
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • AST no greater than 2.5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
  • No uncontrolled congestive heart failure
  • No ventricular dysrhythmia
  • 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
  • No prior systemic biologic response modifier therapy
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • 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
 
NCT00021099
NCI-2012-02390, E3800, U10CA021115, CDR0000068747
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Robert Dreicer Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
January 2013

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