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

Study Overview

• Status: Completed
• Conditions: Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Bladder Cancer; Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Regional Transitional Cell Cancer of the Renal Pelvis and Ureter; Stage III Bladder Cancer; Stage IV Bladder Cancer; Transitional Cell Carcinoma of the Bladder; Distal Urethral Cancer; Proximal Urethral Cancer; Recurrent Urethral Cancer; Urethral Cancer Associated With Invasive Bladder Cancer
• Intervention / Treatment: Drug: ixabepilone

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Eastern Cooperative Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with clinical response measured using RECIST criteria	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Toxicity graded using the NCI CTC version 2.0	Up to 30 days after completion of study treatment

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert Dreicer, Eastern Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: July 11, 2001
• First Submitted That Met QC Criteria: October 8, 2003
• First Posted (Estimate): October 9, 2003

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Disease Attributes; Ureteral Diseases; Urethral Diseases; Kidney Neoplasms; Carcinoma; Recurrence; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Ureteral Neoplasms; Urethral Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones; Epothilone B
• Other Study ID Numbers: NCI-2012-02390; U10CA021115 (U.S. NIH Grant/Contract); E3800; CDR0000068747 (Registry Identifier: PDQ (Physician Data Query))