Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

NCT ID: NCT00021099

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ixabepilone

Intervention Type: DRUG

Given IV

Interventions

ixabepilone

Given IV

Intervention Type: DRUG

Other Intervention Names

BMS-247550; epothilone B lactam; Ixempra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dreicer

Role: PRINCIPAL_INVESTIGATOR

Eastern Cooperative Oncology Group

Locations

Eastern Cooperative Oncology Group

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

E3800

Identifier Type: -

Identifier Source: secondary_id

U10CA021115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068747

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02390

Identifier Type: -

Identifier Source: org_study_id