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
  Purpose

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 Intervention Phase
Carcinoma Renal Cells
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Spanish Oncology Genito-Urinary Group:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 59
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Sunitinib
  • Sutent

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00663559

Contacts
Contact: José Luís González Larriba, MD 913303000 jgonzalezl.hcsc@salud.madrid.org
Contact: Charo Alfonso 913303000 ext 366

Locations
Spain
Hospital Central de Asturias Not yet recruiting
Oviedo, Asturias, Spain, 33006
Contact: Cecilia González    985108000    ceciliagonzalezd@hotmail.com   
Principal Investigator: Emilio Esteban, MD         
Hospital Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Merce Abad    937231010    mabad@cspt.es   
Principal Investigator: Enrique Gallardo, MD         
Hospital CLINIC Recruiting
Barcelona, Spain, 08036
Contact: Begoña Medina, MD    932275400 ext 5523    bmellado@clinic.ub.es   
Contact: Teresa Vilella    932275402    vilella@clinic.ub.es   
Principal Investigator: Begoña Mellado, MD         
Hospital Reina Sofía Not yet recruiting
Córdoba, Spain, 14004
Contact: Isabel Jaraba, MD    957011893    datascordoba@yahoo.es   
Principal Investigator: Enrique Aranda, MD         
Hospital de Jaén Recruiting
Jaén, Spain, 23007
Contact: Capilla De la Torre    953220306    oncojaen@telefonica.net   
Principal Investigator: Ana Lozano, MD         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: Charo Alfonso    913303000 ext 7545      
Principal Investigator: José Luís González Larriba, MD         
Hospital lozano Blesa Not yet recruiting
Zaragoza, Spain, 50009
Contact: Mª José Bardina    976765746      
Principal Investigator: Julio José Lambea, MD         
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Investigators
Study Chair: José Luís González Larriba, MD SOGUG
  More Information

No publications provided

Responsible Party: Dr. Bellmunt Molins, Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT00663559     History of Changes
Other Study ID Numbers: SOGUG/0107
Study First Received: April 21, 2008
Last Updated: April 21, 2008
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on September 16, 2014