Retrospective Chart Review of Valstar

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01304173
First received: February 23, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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
Carcinoma in Situ of Bladder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Event-free survival defined as recurrence, progression or death from any cause


Secondary Outcome Measures:
  • Worsening-free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause


Enrollment: 113
Study Start Date: March 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304173

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Principal Investigator: Michael Cookson, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01304173     History of Changes
Other Study ID Numbers: EN3329-401
Study First Received: February 23, 2011
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Endo Pharmaceuticals:
BCG
refractory
NMIBC
CIS
non-muscle invasive

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

ClinicalTrials.gov processed this record on September 22, 2014