Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Gemcitabine

About this trial

This is an interventional treatment trial for Bladder Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Superficial bladder cancer
No prior chemotherapy

Exclusion Criteria:

Grade 3 tumors
Papillary tumors invading connective tissue
Significant urologic disease, possible interfering with intravesical therapy

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Outcomes

Primary Outcome Measures

To evaluate the response rate

Secondary Outcome Measures

To define the relapse free survival

To assess toxicity profile

Full Information

NCT ID

NCT00491114

First Posted

June 21, 2007

Last Updated

June 21, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00491114

Brief Title

Intravesical Chemotherapy Treatment of Superficial Bladder Cancer

Official Title

Intravesical Gemcitabine Therapy in Intermediate Risk Superficial Bladder Cancer: A Phase II Study With the Marker Lesion

Study Type

Interventional

2. Study Status

Record Verification Date

June 2007

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This is a phase II study where chemotherapy (gemcitabine) is given into the urinary bladder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Primary Outcome Measure Information:

Title

To evaluate the response rate

Secondary Outcome Measure Information:

Title

To define the relapse free survival

Title

To assess toxicity profile

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Superficial bladder cancer No prior chemotherapy Exclusion Criteria: Grade 3 tumors Papillary tumors invading connective tissue Significant urologic disease, possible interfering with intravesical therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name