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Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer

Sponsor
Campania Younger Oncologists Association (Other)
Overall Status
Unknown status
CT.gov ID
NCT00818350
Collaborator
(none)
25
Enrollment
1
Arm
24
Duration (Months)

Study Details

Study Description

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
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2009
Anticipated Primary Completion Date :
Aug 1, 2009
Anticipated Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: SUNITINIB

Drug: SUNITINIB
50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING
Other Names:
  • SUTENT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the antitumor efficacy ( response rate) of sunitinib [12 weeks]

    Secondary Outcome Measures

    1. QOL [6 WEEKS]

    2. TOXICITY ACCORDING NCI VERSION 3 CRITERIA [EVERY WEEK]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Campania Younger Oncologists Association

    Investigators

    • Principal Investigator: DI LORENZO GIUSEPPE, PHD, Campania Younger Oncologists Association

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00818350
    Other Study ID Numbers:
    • AGOC O1
    First Posted:
    Jan 7, 2009
    Last Update Posted:
    Jan 7, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Sunitinib

    Study Results

    No Results Posted as of Jan 7, 2009