Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

This study has been terminated.
(The study was stopped early for futility reasons.)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191477
First received: September 12, 2005
Last updated: September 24, 2009
Last verified: September 2009

September 12, 2005
September 24, 2009
January 2004
March 2008   (final data collection date for primary outcome measure)
Recurrence-Free Survival (RFS) [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
The primary objective of this study is to compare the efficacy of a postoperative intravesical instillation of gemcitabine
Complete list of historical versions of study NCT00191477 on ClinicalTrials.gov Archive Site
  • Time to Recurrence [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
  • Recurrence-Free Survival (RFS) in Subgroups [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
  • Tumor Recurrence Type [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ] [ Designated as safety issue: No ]
  • The secondary objectives:
  • -To compare time to recurrence in both treatment arms
  • -To compare the type of recurrence
  • -To compare the recurrence-free survival in subgroups with and without subsequent BCG treatment
  • -To compare the recurrence-free survival in subgroups with and without prior history of superficial bladder tumor(s)
  • -To characterize the tolerability of a postoperative instillation of gemcitabine
Not Provided
Not Provided
 
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Multicenter Study of Immediate Postoperative Instillation of Gemcitabine in Patients With Superficial Transitional Cell Carcinoma of the Bladder

A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately after transurethral resection of the bladder tumor.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bladder Neoplasms
  • Drug: Gemcitabine
    2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
    Other Names:
    • LY 188011
    • Gemzar
  • Drug: Placebo
    intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
  • Experimental: A
    Intervention: Drug: Gemcitabine
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Böhle A, Leyh H, Frei C, Kühn M, Tschada R, Pottek T, Wagner W, Knispel HH, von Pokrzywnitzki W, Zorlu F, Helsberg K, Lübben B, Soldatenkova V, Stoffregen C, Büttner H; S274 Study Group. Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicentre study. Eur Urol. 2009 Sep;56(3):495-503. Epub 2009 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
355
June 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical evidence of superficial transitional cell carcinoma of the bladder
  • Males or females at least 18 years of age
  • Karnofsky Performance Status greater than or equal to 70%
  • Patient compliance and geographic proximity that allow adequate follow-up
  • Female patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment.
  • Signed informed consent.

Exclusion Criteria:

  • Clinical evidence of muscle-invasive or locally advanced bladder cancer
  • Clinical evidence of upper urinary tract tumor
  • Distant metastases
  • Other malignancies within the last 2 years, except non-melanotic skin tumors, carcinoma in situ of the cervix or organ-confined prostate cancer after curative therapy
  • Severe concomitant psychiatric disease
  • Febrile, active infection
  • Other serious concomitant disorders that would compromise the safety of the patient or his/her ability to complete the study according to the protocol, at the discretion of the investigator (for example, unstable angina pectoris, uncontrolled diabetes mellitus)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00191477
6138, B9E-MC-S274
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Chair: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP