Retrospective Chart Review of Valstar

Carcinoma in Situ of Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304173
• Other study ID #: EN3329-401
• Status: Completed
• Phase: N/A
• First received: February 23, 2011
• Last updated: February 14, 2014
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2014
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma in Situ of Bladder
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Event-free survival defined as recurrence, progression or death from any cause	12 months	No
Secondary	Worsening-free Survival	Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause	12 months	No