Bladder Cancer, Urothelial Carcinoma
Conditions
Keywords
sunitinib, bladder neoplasm, adjuvant treatment, disease free survival, cystectomy
Brief summary
The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal). A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.
Interventions
DRUGSunitinib
Sunitinib 37.5 mg daily X 16 weeks
Sponsors
Pfizer
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic diagnosis of bladder carcinoma (\>50% urothelial carcinoma) * Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy * Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0 * ECOG performance status of 0-1 (Appendix 2). * No evidence of metastases within 4 weeks of registration * Adequate organ and marrow function obtained within 14 days of registration
Exclusion criteria
* Severe or uncontrolled acute or chronic medical or psychiatric condition * Prior antiangiogenic therapy * Prior pelvic radiation for bladder cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 2- year | 2-year disease free survival |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous Daily Dosing of Sunitinib Sunitinib: Sunitinib 37.5 mg daily X 16 weeks | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Continuous Daily Dosing of Sunitinib |
|---|---|
| Age, Customized 18-85 years | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 3 / 7 |
Outcome results
Primary
Disease Free Survival
2-year disease free survival
Time frame: 2- year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 1 Time to Recurrence | 4.7 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 2 Last Follow up. No Recurrence | 21.1 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 3 Time to Recurrence | 21.2 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 4 Last Follow up. No Recurrence | 17.1 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 5 Last Follow up. No Recurrence | 12.3 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 6 Time to Recurrence | 12.2 months |
| Continuous Daily Dosing of Sunitinib | Disease Free Survival | Patient 7 Last Follow up. No Recurrence | 9.4 months |