Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

NCT00191477 | Terminated Phase 3 Results DMC

• 2 other identifiers: 6138B9E-MC-S274
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.

  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 Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (2)

A

EXPERIMENTAL

Drug: Gemcitabine

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gemcitabine DRUG

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

Also known as: LY 188011, Gemzar

A

Placebo DRUG

intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, 23858, Germany

Location

Related Publications (2)

• Han MA, Maisch P, Jung JH, Hwang JE, Narayan V, Cleves A, Hwang EC, Dahm P. Intravesical gemcitabine for non-muscle invasive bladder cancer. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD009294. doi: 10.1002/14651858.CD009294.pub3.

  PMID: 34125951 DERIVED

• Bohle A, Leyh H, Frei C, Kuhn M, Tschada R, Pottek T, Wagner W, Knispel HH, von Pokrzywnitzki W, Zorlu F, Helsberg K, Lubben B, Soldatenkova V, Stoffregen C, Buttner 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. doi: 10.1016/j.eururo.2009.06.010. Epub 2009 Jun 21.

  PMID: 19560257 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study was stopped early for futility reasons. In addition, due to limitations in this databank, some original outcome measures are not disclosed. Time to Recurrence and Recurrence-Free Survival in Subgroups had data that were un-estimated.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

Study Officials

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: January 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 28, 2009
• Results First Posted: October 28, 2009

Record last verified: 2009-09

Locations

DE (1)