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

This study has been completed.
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00696579
First received: June 10, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Bladder Cancer
 Drug: BCG
Drug: gemcitabine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events. [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: January 2004
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
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.
Experimental: 2
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
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

Detailed Description:

This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary urban teaching University Urological Department regarding sixty-four patients with high-risk superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at 3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36 months.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696579

Locations
Italy
1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00696579     History of Changes
Other Study ID Numbers: EC_ML_003
Study First Received: June 10, 2008
Last Updated: June 10, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by University Of Perugia:
BCG
Gemcitabine
Intravesical
Therapy
 Superficial
Transitional
Cell carcinoma

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on June 18, 2013