Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer
Endpoints: Time to recurrence, duration of response and safety
Number of Patients: 53 patients
Study Design: Non-randomized, open-label study.
Key Inclusion Criteria: High-risk patients according to EAU criteria defined as
- pT1 and/or Grade 2b-3, or multiple and highly recurrent
- histologically confirmed carcinoma in situ (CIS)
Key Exclusion Criteria:
pTa Grade 1 or pT1 Grade 1 tumors, existing urinary tract infection or recurrent severe
bacterial cystitis; those who cannot tolerate intravesical administration or intravesical
surgical manipulation due to the presence of concomitant serious illness; no prior
intravesical chemotherapy or immunotherapy in the last three months; no prior EOquin
treatment (intravenous or intravesical) in last 12 months.
All patients will receive intravesical instillation of EOquin™ 4-mg/40 mL instillate once a
week for six consecutive weeks
Patient with carcinoma in situ (CIS) will receive further maintenance therapy with 3
consecutive weekly EOquin instillations at the following time points: 3, 6, 12, 18, and 24
months from the date of TUR. At 3-month follow up visit patients will undergo cystoscopic
bladder biopsy and urine cytology. If bladder biopsy is negative at 3-month visit, the
follow up during the remaining visits will be by cystoscopy and urine cytology only, which
will be done prior to the start of maintenance therapy. In case of positive cytology
presence of CIS has to be confirmed histologically with biopsies.
At 6 months follow-up, if biopsies are positive for CIS, no further maintenance therapy will
be given; patient will be taken off-study.
Duration of Patient Participation:
Intravesical instillation of EOquin™ will be given once a week for six consecutive weeks.
All patients will have follow-up evaluations carried out at 3, 6, 9, 12, 15 and 18 months
from the TUR date or until progressive disease is observed. In case of recurrence, patients
will go off the study and further treatment will be at the investigator's discretion.
Patients will be taken off the study:
- Upon first recurrence and or progression
- Persistent CIS at 6 months follow up
- Recurrent CIS after biopsy proven complete response
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression / Duration of remission following transurethral resection of superficial bladder cancer
Alfred Witjes, MD, Prof.
Urology Division, St Radboud University Hospital, Nijmegen, the Netherlands
Netherlands: Medicines Evaluation Board (MEB)