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Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy

Information source: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma Renal Cells

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Spanish Oncology Genito-Urinary Group

Official(s) and/or principal investigator(s):
José Luís González Larriba, MD, Study Chair, Affiliation: SOGUG


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free survival

Secondary outcome:

Global survival

Response global

Duration of response

Security and tolerability of Sunitinib

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Hospital CLINIC, Barcelona 08036, Spain

Hospital Reina Sofía, Córdoba 14004, Spain

Hospital de Jaén, Jaén 23007, Spain

Hospital Clínico San Carlos, Madrid 28040, Spain

Hospital lozano Blesa, Zaragoza 50009, Spain

Hospital Central de Asturias, Oviedo, Asturias 33006, Spain

Hospital Parc Taulí, Sabadell, Barcelona 08208, Spain

Additional Information

Starting date: February 2008
Last updated: December 17, 2014

Page last updated: August 23, 2015

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