Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

Stage IV Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021099
• Other study ID #: NCI-2012-02390
• Secondary ID: E3800U10CA021115
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: January 23, 2013
• Start date: June 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Distal Urethral Cancer
• Kidney Neoplasms
• 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
• Ureteral Neoplasms
• Urethral Cancer Associated With Invasive Bladder Cancer
• Urethral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• ixabepilone
Given IV

Locations

Country	Name	City	State
United States	Eastern Cooperative Oncology Group	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with clinical response measured using RECIST criteria		Up to 3 years	No
Secondary	Toxicity graded using the NCI CTC version 2.0		Up to 30 days after completion of study treatment	Yes