Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00021099

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: ixabepilone Given IV Other Names: BMS-247550 epothilone B lactam Ixempra

Arm

Intervention/Treatment

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.

Drug: ixabepilone

Given IV

Other Names:

BMS-247550

epothilone B lactam

Ixempra

Outcome Measures

Primary Outcome Measures

The proportion of patients with clinical response measured using RECIST criteria [Up to 3 years]

Secondary Outcome Measures

Toxicity graded using the NCI CTC version 2.0 [Up to 30 days after completion of study treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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