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

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: NCT00663559
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma Renal Cells Drug: Sunitinib Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Sutent

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: every 12 weeks ]

Secondary Outcome Measures :
  1. Global survival [ Time Frame: At last contact date or death date ]
  2. Response global [ Time Frame: Every 12 weeks ]
  3. Duration of response [ Time Frame: Every 12 weeks ]
  4. Security and tolerability of Sunitinib [ Time Frame: Every 4 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00663559

Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital CLINIC
Barcelona, Spain, 08036
Hospital Reina Sofía
Córdoba, Spain, 14004
Hospital de Jaén
Jaén, Spain, 23007
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Study Chair: José Luís González Larriba, MD SOGUG

Responsible Party: Spanish Oncology Genito-Urinary Group Identifier: NCT00663559     History of Changes
Other Study ID Numbers: SOGUG/0107
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: November 2007

Keywords provided by Spanish Oncology Genito-Urinary Group:
Unresectable and/or metastatic renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors