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

Phase 2
18 Years
Not Enrolling
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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)

Type of Study:


Study Design:

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

Outcome Measure:

Response rate as measured by RECIST criteria

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

February 2012

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • recurrent bladder cancer
  • stage IV bladder cancer
  • transitional cell carcinoma of the bladder
  • anterior urethral cancer
  • posterior urethral cancer
  • recurrent urethral cancer
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • recurrent transitional cell cancer of the renal pelvis and ureter
  • urethral cancer associated with invasive bladder cancer
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021