Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy (SOGUG/0107)

December 17, 2014 updated by: Spanish Oncology Genito-Urinary Group

Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy

The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study phase II in with one arm in patients with renal cells carcinoma.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic
      • Córdoba, Spain, 14004
        • Hospital Reina Sofía
      • Jaén, Spain, 23007
        • Hospital de Jaen
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Zaragoza, Spain, 50009
        • Hospital Lozano Blesa
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Central de Asturias
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must give their written informed consent before any procedure related to the study is performed.
  • Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
  • Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
  • Ages equal or superior to 18 years old.
  • ECOG ≤ 1
  • Patients with a life expectancy superior to 12 weeks.

  • Patients with adequate organic function, according to the following criteria:

    1. . Medular reserve: Neutrophils absolute count≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Haemoglobin ≥ 9g/dl
    2. . Hepatic function: Total bilirubin < 1.5 times the superior limit of normality ALT and AST < 2.5 times the superior limit of normality (< 5 times the superior limit of normality in case of liver failure due to cancer)
    3. . Seric Albumin ≥ 1.5 times the superior limit of normality
    4. . Renal Function: Cleary creatinine > 30ml/min
    5. . FEVI > LIN according to ECO or MUGA
  • Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions while on study

Exclusion Criteria:

  • Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
  • Patients that have received sistemic treatment previous to metastasic disease.
  • Previous nefrectomy.
  • Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
  • Radiotherapy upper > 25% bone marrow.
  • Patients that are participating in any clinical trial.
  • Patients with a primary cancer diagnosis in thast 3 years, except superficial basaliomas, superficial escamous carcinoma or in situ cervix carcinoma with aducuate treatment.
  • Following events in the last 12 months previous to begin the treatment: myocardial infarction, unstable o severe angina, coronary/periferic place of arterial by-pass, congestive cardiac insufficiency, brain-vascular accident included transitory ischemia or lung embolism.
  • Arterial uncontrolled hypertension nor controlated with drugs ( >150/100 mmHg despite adequate medical treatment).
  • Cardiac arrhythmia with grade NCI CTCAE ≥2, auricular fibrillation all grade and/or QTc interval> 450mseg in men and > 470 mseg in women.
  • Actually treatment with therapeutic dose with acenocumarol (except low dose for deep venous thrombosis).
  • Patients that present previously known positive serology for HIV.
  • Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
This study has only one arm with Sunitinib
Drug: Sunitinib
Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
Other Names:
  • Sutent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: every 12 weeks
every 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Global survival
Time Frame: At last contact date or death date
At last contact date or death date
Response global
Time Frame: Every 12 weeks
Every 12 weeks
Duration of response
Time Frame: Every 12 weeks
Every 12 weeks
Security and tolerability of Sunitinib
Time Frame: Every 4 weeks
Every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Investigators

  • Study Chair: José Luís González Larriba, MD, SOGUG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 21, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOGUG/0107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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