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A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial bladder tumors, and the response and duration of response in patients with carcinoma in situ of the bladder.
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
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intravesical instillation of EOquin (apaziquone)
St Radboud University Hospital
Active, not recruiting
Spectrum Pharmaceuticals, Inc
Published on BioPortfolio: 2014-07-23T21:50:44-0400
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