LCI-GU-BLA-SPEC-001: Aurora Kinase Expression in Muscle-Invasive Bladder Cancer

LCI-GU-BLA-SPEC-001: Expression of the Aurora Kinase Family and Chemoresistance in Muscle-Invasive Bladder Cancer

This is a prospective, single arm, observational study examining aurora kinases and circulating tumor cells in subjects with bladder cancer being treated with standard cisplatin-based chemotherapy.

Study Overview

• Status: Terminated
• Conditions: Bladder Cancer

Detailed Description

Subjects will receive neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy per standard of care. CTC and Aurora kinase expression patterns will be analyzed in subject specimens for correlation with clinicopathologic outcome. Subjects will be on study for a total of five years following cystectomy.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Healthcare System

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with muscle-invasive urothelial carcinoma of the bladder

Description

Inclusion Criteria

• Histologically confirmed American Joint Committee on Cancer seventh edition clinical stage T2-4a N0-3 urothelial carcinoma of the bladder based on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT) confirming the presence of urothelial carcinoma with muscularis propria invasion.
• Archived tissue from prior biopsy/resection must be available for baseline AK analysis.
• Subjects must be eligible to undergo radical cystectomy and cisplatin-based chemotherapy.
• Subjects with radiographically enlarged lymph nodes (short axis >10 mm with CT scan or MRI) should undergo percutaneous biopsy for staging in accordance with local practices, though preferred, is not mandatory for study enrollment.
• A baseline computed tomography (CT) scan with intravenous contrast of the chest, abdomen and pelvis is required in all subjects. A radionuclide bone scan is also required in subjects with skeletal pain or abnormally elevated alkaline phosphatase values.
• Age at least 18 years old.
• ECOG performance status of 0 or 1.
• Bilirubin less than 1.5 mg/dL.
• Subjects must have adequate liver function: AST and ALT less than 2.5x upper limit of normal, alkaline phosphatase less than 2.5x upper limit of normal.
• Subjects must have adequate bone marrow function: Platelets greater than 100,000 cells/mm3, Hemoglobin greater than 9.0g/dL and ANC greater than 1,500 cells/mm3.
• Subjects must have adequate renal function with creatinine clearance of at least 60 mL/min.
• Subjects must sign a written informed consent document and authorization for release of their medical records for the purposes of research.

Exclusion Criteria

• Pure non-urothelial or mixed small cell histology identified within TURBT specimen.
• Absence of documented urothelial carcinoma with muscularis propria invasion on diagnostic transurethral bladder biopsy or transurethral resection of bladder tumor (TURBT).
• Distant metastatic disease, including non-regional lymphadenopathy and visceral metastases, identified on pretreatment radiographic studies.
• Creatinine clearance less than 60 mL/min.
• CTCAE version 4 grade 2 or greater hearing loss.
• CTCAE version 4 grade 2 or greater peripheral neuropathy.
• NYHA class III heart failure or cardiac ejection fraction less than or equal to 50%.
• Women of child-bearing age who are pregnant or breast feeding.
• Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects with other active malignancies as defined as synchronous malignancy at the time of bladder cancer diagnosis, excluding non-metastatic, non-melanoma skin cancer are excluded.
• Major surgery within 4 weeks of consent.
• Subjects requiring therapeutic anticoagulation at the time of consent.
• Currently enrolled on another clinical trial for the treatment of bladder cancer.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single Arm; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of pathologic response rate and aurora kinase expression	Within 6 months of subject enrollment

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: University of Miami
• Investigators: Principal Investigator: Tesa M Adams, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: LCI-GU-BLA-SPEC-001; 00009729