Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141531
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-08-30
Brief Title:
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
Phase II Study of Intravesical Instillation of EOQUIN in High Risk Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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
Study Treatment
All patients will receive intravesical instillation of EOquin 4-mg40 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 investigators discretion
Off Study
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
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 andor 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
Study Treatment
All patients will receive intravesical instillation of EOquin 4-mg40 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 investigators discretion
Off Study
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 503 | None | None | None |