Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer|
- Time to progression / Duration of remission following transurethral resection of superficial bladder cancer [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Additional safety data [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Rate of upstaging on recurrence [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Apaziquone||
Apaziquone (EOquinTM) 4 mg/40 mL was administered by intravesical instillation once a week for 6 consecutive weeks.
In addition, patients with CIS were to receive further maintenance therapy of 3 weekly apaziquone (EOquinTM) instillations at 3, 6, and 12 months from the date of histological diagnosis.
Other Name: EOquin
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141531
|St Radboud University Hospital|
|Study Chair:||Alfred Witjes, MD, Prof.||Urology Division, St Radboud University Hospital, Nijmegen, the Netherlands|
|Study Director:||Kees Hendricksen, MD||St Radboud University Hospital, Nijmegen, the Netherlands|