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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

Phase 2
18 Years
Open (Enrolling)
Carcinoma Renal Cells

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Trial Information

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 12 weeks

Safety Issue:


Principal Investigator

José Luís González Larriba, MD

Investigator Role:

Study Chair

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

February 2008

Completion Date:

February 2010

Related Keywords:

  • Carcinoma Renal Cells
  • renal
  • Sunitinib
  • Unresectable and/or metastatic renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell