Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Spectrum Pharmaceuticals, Inc |
---|---|
Information provided by: | Spectrum Pharmaceuticals, Inc |
ClinicalTrials.gov Identifier: | NCT00141531 |
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.
Condition | Intervention | Phase |
---|---|---|
Bladder Neoplasms |
Drug: Intravesical instillation of EOquin (apaziquone) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Intravesical Instillation of EOQUIN™ in High Risk Superficial Bladder Cancer |
Estimated Enrollment: | 53 |
Study Start Date: | August 2005 |
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
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.
Study Treatment:
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.
Off Study:
Patients will be taken off the study:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Patients with high risk superficial bladder cancer according to EAU criteria defined as:
Exclusion Criteria:
Netherlands | |
St Radboud University Hospital | |
Nijmegen, Netherlands |
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 |
Study ID Numbers: | SPI 05-003, 503 |
Study First Received: | August 30, 2005 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00141531 |
Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Bladder cancer Superficial Carcinoma in situ |
Intravesical instillation Chemotherapy Adjuvant |
Cystocele Urologic Diseases Carcinoma in Situ Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms |
Urologic Neoplasms EO 9 Urinary tract neoplasm Bladder neoplasm Carcinoma |
Neoplasms Neoplasms by Site |