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

University Of Perugia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bladder Cancer

Treatments: Drug: BCG; Drug: gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00696579

EC_ML_003

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

A

Active Comparator group

Description:

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.

Treatment:

Drug: BCG

2

Experimental group

Description:

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

Treatment:

Drug: gemcitabine