Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

NCT00021099 | Completed Phase 2

• 4 other identifiers: NCI-2012-02390E3800U10CA021115CDR0000068747
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with clinical response measured using RECIST criteria

  Up to 3 years

Secondary Outcomes (1)

• Toxicity graded using the NCI CTC version 2.0

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

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

Interventions

ixabepilone DRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra

Treatment (ixabepilone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Study Officials

• Robert Dreicer

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: October 9, 2003
• Study Start: June 1, 2001
• Primary Completion: August 1, 2007
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)