Retrospective Chart Review of Valstar

A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice

This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Study Overview

• Status: Completed
• Conditions: Carcinoma in Situ of Bladder

Detailed Description

Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University

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 who have been treated with valrubicin in a clinical practice setting.

Description

Inclusion Criteria:

• age 18 years old or greater
• diagnosis of CIS (physician defined in the medical record)
• treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
• willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117

Exclusion Criteria:

• route of administration of valrubicin other than intravesical

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival	Event-free survival defined as recurrence, progression or death from any cause	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worsening-free Survival	Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause	12 months

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Principal Investigator: Michael Cookson, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: NMIBC; refractory; CIS; BCG; non-muscle invasive
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Carcinoma
• Other Study ID Numbers: EN3329-401