Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Neoplasms

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Recurrence-Free Survival (RFS)

Outcome 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)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Chair

Investigator Affiliation:

Eli Lilly and Company

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

6138

NCT ID:

NCT00191477

Start Date:

January 2004

Completion Date:

June 2008

Related Keywords:

  • Bladder Neoplasms
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma, Transitional Cell

Name

Location