Bladder Cancer Stage 1 without Cancer in Situ Patients will have transitional-cell carcinoma of the bladder, clinical TNM stage Ta or T1 and histologic grade G1 or G2 before transurethral resection. MedDRA version: 9 Level: PT Classification code 10005009
Conditions
Interventions
Product Name: EOquin
Pharmaceutical Form: Powder for bladder irrigation
Sponsors
Spectrum Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following inclusion criteria must be met in order for the patient to be eligible for the study: 1. Transitional-cell carcinoma of the bladder, clinical TNM stage Ta or T1 and histologic grade G1 or G2 before transurethral resection. 2. Absolute neutrophil count =1.5 x109/L, platelets = 100 x109/L, serum creatinine and bilirubin = 1.5 x upper limit of local norm (ULN), serum GOP and GPT = 3 xULN 3. Women of child-bearing age must have a negative pregnancy test. 4. All patients must agree to use an effective method of contraception 5. ECOG performance status of 0-2 6. Age =18 7. Patient fully informed of the investigational nature of the study; signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Likelihood of muscle-invasive (T2) or higher stage disease, or carcinoma in situ. 2. Recurrence within 3 months from the last previous manifestation of SBC 3. More than 5 lesions or largest diameter = 4 cm 4. Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months 5. Previous treatment with EOquin™ by intravesical or intravenous administration 6. Patients with other malignancies except resected basal cell cancer/squamous carcinoma of the skin 7. Patients with any significant GU disease 8. Patients with prior intravesical BCG therapy 9. Patients with bladder perforation, suspected bladder perforation, or deep resection exposing perivesical fat. 10. Active urinary tract infection or recurrent severe bacterial cystitis 11. Urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra 12. Patients who, in the opinion of the investigator, cannot tolerate general anesthesia, intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders) 13. Pregnancy or lactation. Any immune deficiency condition or known HIV infection 14. Patient unlikely to comply with the provisions of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety of a single immediate post-TUR intravesical instillation of 4 mg/40 ml EOquin;Secondary Objective: To evaluate the pharmacokinetics of EOquin™ following immediate post-TUR intravesical instillation.;Primary end point(s): The primary endpoint of the study is to be determined by 2 main assessments: 1. Presence, severity and frequency of adverse events / toxicities in the 2 weeks following the instillation 2. For the first 10 patients with low-risk histology, cystoscopic evaluation of bladder epithelium approximately 3 months (10-13 weeks) after immediate post-TUR instillation Patients will be initially enrolled in the study based on the Investigator's judgment of the probable stage and grade of the tumor. Clinical assessment of the probable tumor stage and grade and adequacy of the resection will be confirmed only later by histopathologic examination of the resection specimen. As a result, all patients enrolled in the study will have received an immediate post-TUR instillation of EOquin™. A first instillation of a cytotoxic agent within few hours from TUR is a generally recommended initial treatment for patients presenting with superficial bladder cancer of all histologic grades at stages Ta and T1, even if further instillation treatment with BCG or cytostatics is indicated because of other prognostic characteristics. The need for those patients to receive further instillation therapy, which is generally given approximately 2 weeks after TUR, will preclude them from being evaluable at the cystoscopy approximately 3 months after TUR. These higher risk patients will receive further instillation therapy after their evaluation on day 15 of this study. | — |
Countries
Netherlands
Outcome results
None listed