Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

Bladder Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00191477
• Other study ID #: 6138
• Secondary ID: B9E-MC-S274
• Status: Terminated
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 24, 2009
• Start date: January 2004
• Est. completion date: June 2008

Study information

• Verified date: September 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 355
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• Gemcitabine
2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
• Placebo
intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS)		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)	No
Secondary	Time to Recurrence		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)	No
Secondary	Recurrence-Free Survival (RFS) in Subgroups		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)	No
Secondary	Tumor Recurrence Type		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)	No

External Links

•   Lilly Clinical Trial Registry