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Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

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Lilly

Status and phase

Terminated
Phase 3

Conditions

Bladder Neoplasms

Treatments

Drug: Placebo
Drug: Gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191477
6138
B9E-MC-S274

Details and patient eligibility

About

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.

Enrollment

355 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

355 participants in 2 patient groups, including a placebo group

A
Experimental group
Treatment:
Drug: Gemcitabine
B
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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