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

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01042795
• Collaborator: Pfizer (Industry)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma; Bladder Cancer	Drug: Sunitinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous Daily Dosing of Sunitinib	Drug: Sunitinib; Sunitinib 37.5 mg daily X 16 weeks; Other Names: Sutent

Outcome Measures

Primary Outcome Measures

1. Disease Free Survival [2- year]

   2-year disease free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan
• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cheryl Lee, Associate Professor of Urology, University of Michigan
• ClinicalTrials.gov Identifier: NCT01042795
• Other Study ID Numbers: HUM00030127
• First Posted: Jan 6, 2010
• Last Update Posted: Jun 28, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cheryl Lee, Associate Professor of Urology, University of Michigan: sunitinib; bladder neoplasm; adjuvant treatment; disease free survival; cystectomy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Continuous Daily Dosing of Sunitinib
Arm/Group Description	Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Period Title: Dosing Period - 16 Weeks of Daily Doses
STARTED	7
COMPLETED	2
NOT COMPLETED	5
Period Title: Dosing Period - 16 Weeks of Daily Doses
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Continuous Daily Dosing of Sunitinib
Arm/Group Description	Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Overall Participants	7
Age, Customized (Count of Participants)
18-85 years	7 100%
Sex: Female, Male (Count of Participants)
Female	3 42.9%
Male	4 57.1%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Disease Free Survival
Description	2-year disease free survival
Time Frame	2- year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continuous Daily Dosing of Sunitinib
Arm/Group Description	Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Measure Participants	7
Patient 1 Time to Recurrence	4.7
Patient 2 Last Follow up. No Recurrence	21.1
Patient 3 Time to Recurrence	21.2
Patient 4 Last Follow up. No Recurrence	17.1
Patient 5 Last Follow up. No Recurrence	12.3
Patient 6 Time to Recurrence	12.2
Patient 7 Last Follow up. No Recurrence	9.4

Adverse Events

Time Frame	21.5 months - after that point no one was still in the trial
Arm/Group Title	Continuous Daily Dosing of Sunitinib
Arm/Group Description	Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
All Cause Mortality
	Continuous Daily Dosing of Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Continuous Daily Dosing of Sunitinib
	Affected / at Risk (%)	# Events
Total	3/7 (42.9%)
Blood and lymphatic system disorders
anemia	1/7 (14.3%)
Gastrointestinal disorders
mucositis	1/7 (14.3%)
Infections and infestations
pyelonephritis	1/7 (14.3%)
Other (Not Including Serious) Adverse Events
	Continuous Daily Dosing of Sunitinib
	Affected / at Risk (%)	# Events
Total	7/7 (100%)
Blood and lymphatic system disorders
neutropenia	6/7 (85.7%)
thrombocytopenia	3/7 (42.9%)
Cardiac disorders
cardiac dysfunction	1/7 (14.3%)
Gastrointestinal disorders
diarrhea	5/7 (71.4%)
nausea	5/7 (71.4%)
General disorders
fatigue	3/7 (42.9%)
Vascular disorders
hypertension	3/7 (42.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.