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Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Campania Younger Oncologists Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Campania Younger Oncologists Association
ClinicalTrials.gov Identifier:
NCT00818350
First received: January 5, 2009
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Urinary Bladder Neoplasms
Drug: SUNITINIB
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Campania Younger Oncologists Association:

Primary Outcome Measures:
  • To determine the antitumor efficacy ( response rate) of sunitinib [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QOL [ Time Frame: 6 WEEKS ] [ Designated as safety issue: Yes ]
  • TOXICITY ACCORDING NCI VERSION 3 CRITERIA [ Time Frame: EVERY WEEK ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUNITINIB Drug: SUNITINIB
50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING
Other Name: SUTENT

Detailed Description:

OBJECTIVES

  • 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.

EVALUATION

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
  • QoL every cycle EORTC-QOL-C30.• RESOURCE UTILIZATION ASSESSMENTS

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 .

STATISTICAL METHODS

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818350

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

No publications provided

Responsible Party: DI LORENZO GIUSEPPE, AGOC
ClinicalTrials.gov Identifier: NCT00818350     History of Changes
Other Study ID Numbers: AGOC O1
Study First Received: January 5, 2009
Last Updated: January 6, 2009
Health Authority: Italy: National Institute of Health

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014