Retrospective Chart Review of Valstar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01304173
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 19, 2014
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief 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.

Condition or disease
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
Actual Enrollment : 113 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 12 months ]
    Event-free survival defined as recurrence, progression or death from any cause

Secondary Outcome Measures :
  1. Worsening-free Survival [ Time Frame: 12 months ]
    Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have been treated with valrubicin in a clinical practice setting.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01304173

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Principal Investigator: Michael Cookson, MD Vanderbilt University Medical Center

Responsible Party: Endo Pharmaceuticals Identifier: NCT01304173     History of Changes
Other Study ID Numbers: EN3329-401
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Endo Pharmaceuticals:
non-muscle invasive

Additional relevant MeSH terms:
Carcinoma in Situ
Urinary Bladder Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases