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Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

This study has been terminated.
(The study was stopped early for futility reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191477
First Posted: September 19, 2005
Last Update Posted: October 28, 2009
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.
Information provided by:
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Bladder Neoplasms Drug: Gemcitabine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]

Enrollment: 355
Study Start Date: January 2004
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Gemcitabine
2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Other Names:
  • LY 188011
  • Gemzar
Placebo Comparator: B Drug: Placebo
intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

  Eligibility

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
Criteria

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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00191477


Locations
Germany
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559,1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physici
Reinfeld, Germany, 23858
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191477     History of Changes
Other Study ID Numbers: 6138
B9E-MC-S274
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: March 17, 2009
Results First Posted: October 28, 2009
Last Update Posted: October 28, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs