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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397488
Recruitment Status : Completed
First Posted : November 9, 2006
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Drug: sunitinib malate Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium
Study Start Date : September 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: Sunitinib
This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma. Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population. A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle. Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression.
Drug: sunitinib malate

Primary Outcome Measures :
  1. Overall Objective Response [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397488

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Dean F. Bajorin, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00397488    
Other Study ID Numbers: 06-081
First Posted: November 9, 2006    Key Record Dates
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016
Last Verified: December 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action