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

NCT01042795 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HUM00030127
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma; Bladder Cancer

Keywords

sunitinib; bladder neoplasm; adjuvant treatment; disease free survival; cystectomy

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  2-year disease free survival

  2- year

Study Arms (1)

Continuous Daily Dosing of Sunitinib

EXPERIMENTAL

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib 37.5 mg daily X 16 weeks

Also known as: Sutent

Continuous Daily Dosing of Sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe or uncontrolled acute or chronic medical or psychiatric condition
• Prior antiangiogenic therapy
• Prior pelvic radiation for bladder cancer

Sponsors & Collaborators

• University of Michigan: lead
• Pfizer: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Cheryl T. Lee
• Organization: University of Michigan

cheryl.lee@osumc.edu

614-685-6666

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)