Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer

NCT00696579 | Completed Phase 1

• 1 other identifier: EC_ML_003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer

Conditions

Bladder Cancer

Keywords

BCG; Gemcitabine; Intravesical; Therapy; Superficial; Transitional; Cell carcinoma

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points

Secondary Outcomes (1)

• Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events.

Study Arms (2)

A

ACTIVE COMPARATOR

Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

Drug: BCG

2

EXPERIMENTAL

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

Drug: gemcitabine

Interventions

BCG DRUG

6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.

A

gemcitabine DRUG

14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/),
• Having never been treated with other intravesical chemotherapeutic agents,
• And to consent to participate to the study

You may not qualify if:

• Concomitant tumours;
• Urinary tract infections (UTI);
• Altered function of the liver, kidneys and/or bone marrow;
• Major cardiovascular diseases;
• Life expectancy of less than 1 year;
• Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6 months;
• Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy

Perugia, 06100, Italy

Location

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: January 1, 2004
• Primary Completion: March 1, 2008
• Last Updated: June 12, 2008

Record last verified: 2008-06

Locations

IT (1)