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

NCT02164942 | Terminated DMC

• 2 other identifiers: LCI-GU-BLA-SPEC-00100009729
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of pathologic response rate and aurora kinase expression

  Within 6 months of subject enrollment

Study Arms (1)

Single Arm

Specimen Collection

Eligibility Criteria

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

Study Population

Patients with muscle-invasive urothelial carcinoma of the bladder

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of Miami: collaborator

Study Sites (1)

Carolinas Healthcare System

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Officials

• Tesa M Adams

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 26, 2022

Record last verified: 2017-08

Locations

US (1)