Clinical trial NCT00663559: Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma Renal Cells
Keywords: renal
Sunitinib
Unresectable and/or metastatic renal cell cancer
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: every 12 weeks
Secondary outcomes:
measure: Global survival
timeFrame: At last contact date or death date
measure: Response global
timeFrame: Every 12 weeks
measure: Duration of response
timeFrame: Every 12 weeks
measure: Security and tolerability of Sunitinib
timeFrame: Every 4 weeks
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital CLINIC
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Jaén
country: Spain
facility: Hospital de Jaén
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Zaragoza
country: Spain
facility: Hospital lozano Blesa
Study officials:
affiliation: SOGUG
name: José Luís González Larriba, MD
role: STUDY_CHAIR
References: