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A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer

NCT ID: NCT00192049

Last Updated: 2007-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-04-30

Brief Summary

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Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma. On the basis of Gemcitabine clinical activity and good tolerability this drug has been recently tested in intravesical therapy. we consider Gemcitabine as a good therapy candidate for patient with intermediate risk superficial bladder cancer. Based on the phase I/II clinical trials w are going to explore the efficacy and tolerability of Gemcitabine in this setting, and compare it to Mitomycin C which is widely used in this group of patients.

Detailed Description

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Conditions

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Superficial Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

mitomycin C

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically verified superficial transitional cell carcinoma of the bladder.
* patients with primary or recurrent intermediate risk superficial bladder cancer after TUR. Patients with primary tumor with stage TaG1 with multiple lesions (\>3) or lesions bigger than 3 cm or patients with TaG2-3 or T1G1-2.
* Patients must not be pre-treated with any intravesical immunotherapy (BCG) or chemotherapy.
* Male or female, age greater than 18.

Exclusion Criteria

* Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks.
* Patients who have received previous (BCG) or chemotherapy.
* Patients with evidence of invasive, locally advanced or metastatic bladder cancer (greater than or equal to T2 disease; stage greater than or equal to B1) or patients with upper urinary tract disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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 physician

Beersheba, , Israel

Site Status

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 physician

Haifa, , Israel

Site Status

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 physician

Jerusalem, , Israel

Site Status

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 physician

Kfar Saba, , Israel

Site Status

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 physician

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 34125951 (View on PubMed)

Other Identifiers

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B9E-MC-S344

Identifier Type: -

Identifier Source: secondary_id

8048

Identifier Type: -

Identifier Source: org_study_id