Clinical trial NCT01475266: Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
Official title: Randomized, Placebo-controlled, Double-blinded Study of Single Immediate Instillation of EO9 After TURBT in Patients With NMIBC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Bladder Cancer
Keywords: Bladder Cancer
NMIBC
TURBT
Apaziquone
EOquin
Immediate instillation
Lead sponsor: Nippon Kayaku Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Handok Inc.
First posted: 2011-11-21
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group after TURBT.


Eligibility criteria: Inclusion Criteria:

1. Patients who have provided written informed consent
2. Patients who have urothelial cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2 and satisfy both of the following criteria:

   * The maximum number of tumors is 5.
   * Each tumor diameter: ≤ 3.5 cm.
3. Age: ≥20 years old at enrollment.
4. The functions of the major organs are adequate, and the following test value criteria are satisfied:

   * Neutrophil count ≥1,500/μL
   * Platelet count ≥10×10\^4/μL
   * Hemoglobin ≥10 g/dL

Exclusion Criteria:

1. Patients with a single, primary bladder cancer of \<0.5 cm.
2. Patients with CIS lesions in the bladder or a history thereof.
3. Patients with a history of other than stage Ta, histological grade G1 or G2 disease.
4. Patients experiencing recurrence within 4 months following TURBT for prior NMIBC (duration between the last TURBT and cystoscopic confirmation of the present recurrence is within 4 months).
5. Patients without at least a three-month cystoscopically confirmed recurrence-free interval between the last TURBT and the time of study screening
6. Patients having a bladder tumor with a histological diagnosis other than urothelial carcinoma of the bladder or a history thereof.
7. Patients who had been administered EO9 in the past.
8. Patients who had been administered any other investigational drug within the past 30 days.
9. Patients having a medical condition that would make it unsafe for them to undergo TURBT under general or spinal anesthesia.

Primary outcomes:
measure: The recurrence rate at 2 years in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
timeFrame: 2 years
Secondary outcomes:
measure: The recurrence-free interval in patients with histologically diagnosed stage Ta, grade G1 or G2 bladder cancer
timeFrame: 2 years
measure: The progression rate
timeFrame: 2 years
measure: The number of recurrences per patient
timeFrame: 2 years
measure: The progression-free survival period
timeFrame: 2 years
measure: The recurrence-free survival period
timeFrame: 2 years
measure: The overall survival period
timeFrame: 2 years
measure: The safety of EO9
timeFrame: 2 years
Other outcomes:
Locations:
city: Yokosuka
country: Japan
facility: Nippon Kayaku Investigational site 103
state: Kanagawa
city: Kashihara
country: Japan
facility: Nippon Kayaku Investigational site 107
state: Nara
city: Kurashiki
country: Japan
facility: Nippon Kayaku Investigational site 109
state: Okayama
city: Osakasayama
country: Japan
facility: Nippon Kayaku Investigational site 105
state: Osaka
city: Hamamatsu
country: Japan
facility: Nippon Kayaku Investigational site 104
state: Shizuoka
city: Musashino
country: Japan
facility: Nippon Kayaku Investigational site 102
state: Tokyo
city: Chiba
country: Japan
facility: Nippon kayaku Investigational site 101
city: Fukuoka
country: Japan
facility: Nippon Kayaku Investigational site 110
city: Fukuoka
country: Japan
facility: Nippon Kayaku Investigational site 111
city: Nara
country: Japan
facility: Nippon Kayaku Investigational site 106
city: Okayama
country: Japan
facility: Nippon Kayaku Investigational site 108
city: Bundang
country: Korea, Republic of
facility: Handok Investigational site 203
city: Daegu
country: Korea, Republic of
facility: Handok Investigational site 202
city: Hwasun
country: Korea, Republic of
facility: Handok Investigational site 209
city: Seoul
country: Korea, Republic of
facility: Handok Investigational site 201
city: Seoul
country: Korea, Republic of
facility: Handok Investigational site 204
city: Seoul
country: Korea, Republic of
facility: Handok Investigational site 205
city: Seoul
country: Korea, Republic of
facility: Handok Investigational site 206
city: Seoul
country: Korea, Republic of
facility: Handok Investigational site 207
city: Yangsan
country: Korea, Republic of
facility: Handok Investigational site 208
Study officials:
affiliation: Nippon Kayaku Co., Ltd.
name: Yoshihiro Nambu, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Handok Inc.
name: Woo Ick Jang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: