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Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

University of Michigan logo

University of Michigan

Status and phase

Terminated
Phase 2

Conditions

Bladder Cancer
Urothelial Carcinoma

Treatments

Drug: Sunitinib

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01042795
HUM00030127

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

Continuous Daily Dosing of Sunitinib
Experimental group
Treatment:
Drug: Sunitinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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