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Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

Primary Purpose

Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Urethral Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Cooperative Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ixabepilone)

Arm Description

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

Outcomes

Primary Outcome Measures

The proportion of patients with clinical response measured using RECIST criteria

Secondary Outcome Measures

Toxicity graded using the NCI CTC version 2.0

Full Information

First Posted
July 11, 2001
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00021099
Brief Title
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
Official Title
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ixabepilone)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
ixabepilone
Other Intervention Name(s)
BMS-247550, epothilone B lactam, Ixempra
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
The proportion of patients with clinical response measured using RECIST criteria
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Toxicity graded using the NCI CTC version 2.0
Time Frame
Up to 30 days after completion of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Dreicer
Organizational Affiliation
Eastern Cooperative Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Cooperative Oncology Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

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