Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Bladder Cancer Clinical Trial

Official title:

Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397488
• Other study ID #: 06-081
• Secondary ID: MSKCC-06081
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2006
• Last updated: December 17, 2015
• Start date: September 2006
• Est. completion date: February 2012

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

Description:

OBJECTIVES:

Primary

• Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.

• Determine the safety of this regimen in these patients.

Secondary

• Determine the time to disease progression in patients treated with this regimen.

• To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.

• To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:

• Bladder

• Urethra

• Ureter

• Renal pelvis

• Progressive metastatic disease

• Progressive disease defined as new or progressive lesions on cross-sectional imaging

• Progressed despite prior treatment with cytotoxic chemotherapy

• Measurable disease

• Previously treated disease, as defined by the following:

• Received treatment with 1-4 cytotoxic agents

• Prior therapy must have included = 1 of the following:

• Cisplatin

• Carboplatin

• Paclitaxel

• Docetaxel

• Gemcitabine hydrochloride

• Prior cytotoxic agents in the perioperative or metastatic setting allowed and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or all as part of a single regimen

• No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Absolute neutrophil count = 1,000/mm³

• Platelet count = 100,000/mm³

• Hemoglobin = 8.0 g/dL

• Bilirubin = 1.5 mg/dL (unless Gilbert's disease is present)

• AST and ALT = 2.5 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)

• Creatinine = 2.0 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• None of the following within the past 6 months:

• Myocardial infarction

• Severe or unstable angina

• Coronary or peripheral artery bypass graft

• Symptomatic congestive heart failure

• Cerebrovascular accident or transient ischemic attack

• Pulmonary embolism

• No ongoing cardiac dysrhythmias = grade 2

• No prolonged QTc interval on baseline ECG

• No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal medical therapy

• No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be maintained in the normal range with medication)

• No known HIV- or AIDS-related illness or other active infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy or chemotherapy

• At least 4 weeks since prior major surgery

• No other concurrent investigational drugs

• No concurrent participation in another clinical trial (supportive care trials or non-treatment trials [e.g., quality of life] allowed)

• No concurrent therapeutic doses of warfarin (low-dose warfarin = 2 mg once daily for thromboembolic prophylaxis allowed)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• sunitinib malate

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Objective Response	Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria	2 years	No