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Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

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: NCT00818350
Recruitment Status : Unknown
Verified January 2009 by Campania Younger Oncologists Association.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2009
Last Update Posted : January 7, 2009
Information provided by:
Campania Younger Oncologists Association

Brief Summary:

Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.

Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.

No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.

Several drugs have been used in second line for metastatic disease with poor results.

The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).

No previous studies have been published with sunitinib in metastatic bladder cancer.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Drug: SUNITINIB Phase 1 Phase 2

Detailed Description:


  • PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib
  • SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) and overall survival (OS).

PLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.

Sunitinib was self-administered orally once daily without regard to meals. Dose reduction for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of toxicity encountered.

Sunitinib treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.


Baseline evaluations included:

  • medical history
  • physical examination;
  • tumor assessment (total body TC and bone scan )
  • assessment of ECOG PS
  • QoL assessment
  • Assessment of left ventricular ejection fraction by echocardiography
  • ECG
  • Laboratory measurements. Assessment of efficacy and safety
  • Evaluation according RECIST criteria every 2 cycles (12 weeks) with TC
  • Safety according NCI version 3 every cycle

EORTC QLQ-C30 questionnaire, developed by the EORTC for the measurement of quality of life in cancer patients in clinical trials.

For the analysis, the raw scores of the questionnaire are transformed into a 100-point scale. For the functional scales, the computed scores range from 0 to 100, with the higher scores representing a higher level of functioning. For the item scales relative to physical symptoms and financial impact, higher scores represent a higher level of symptoms or problems .


Benefit anticipated (%): >30% of response rate. Test size: 5%. Power 80%. Sample size: 25 patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer
Study Start Date : January 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Other Name: SUTENT

Primary Outcome Measures :
  1. To determine the antitumor efficacy ( response rate) of sunitinib [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. QOL [ Time Frame: 6 WEEKS ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • cytological confirmation of UROTHELIAL carcinoma
  • Failure of Cisplatin-gemcitabine regimen as first-line
  • Presence of measurable metastases
  • Performance status 0-1 ECOG
  • Age of 18 years or older
  • Written informed consent
  • Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).

Exclusion Criteria:

  • administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
  • brain metastases
  • significant cardiac events within the 6 months prior to study drug administration.

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): NCT00818350

Sponsors and Collaborators
Campania Younger Oncologists Association
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Principal Investigator: DI LORENZO GIUSEPPE, PHD Campania Younger Oncologists Association

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Responsible Party: DI LORENZO GIUSEPPE, AGOC Identifier: NCT00818350     History of Changes
Other Study ID Numbers: AGOC O1
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic 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