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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Spanish Oncology Genito-Urinary Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT00663559
First received: April 21, 2008
Last updated: NA
Last verified: November 2007
History: No changes posted

April 21, 2008
April 21, 2008
February 2008
August 2009   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Global survival [ Time Frame: At last contact date or death date ] [ Designated as safety issue: No ]
  • Response global [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Security and tolerability of Sunitinib [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
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 phase II in with one arm in patients with renal cells carcinoma.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma Renal Cells
Drug: Sunitinib
Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
Other Names:
  • Sunitinib
  • Sutent
1
This study has only one arm with Sunitinib
Intervention: Drug: Sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
59
February 2010
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: José Luís González Larriba, MD 913303000 jgonzalezl.hcsc@salud.madrid.org
Contact: Charo Alfonso 913303000 ext 366
Spain
 
NCT00663559
SOGUG/0107
Yes
Dr. Bellmunt Molins, Spanish Oncology Genito-Urinary Group
Spanish Oncology Genito-Urinary Group
Not Provided
Study Chair: José Luís González Larriba, MD SOGUG
Spanish Oncology Genito-Urinary Group
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP