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

NCT00663559 | Completed Phase 2 DMC

• 1 other identifier: SOGUG/0107
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 7

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.

Conditions

Carcinoma Renal Cells

Keywords

renal; Sunitinib; Unresectable and/or metastatic renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  every 12 weeks

Secondary Outcomes (4)

• Global survival

  At last contact date or death date

• Response global

  Every 12 weeks

• Duration of response

  Every 12 weeks

• Security and tolerability of Sunitinib

  Every 4 weeks

Study Arms (1)

1

OTHER

This study has only one arm with Sunitinib

Drug: Sunitinib

Interventions

Sunitinib DRUG

Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.

Also known as: Sutent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Medular reserve: Neutrophils absolute count≥ 1.5 x 10\^9/L Platelets ≥ 100 x 10\^9/L Haemoglobin ≥ 9g/dl
• 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)
• Seric Albumin ≥ 1.5 times the superior limit of normality
• Renal Function: Cleary creatinine \> 30ml/min
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (7)

Hospital CLINIC

Barcelona, Barcelona, 08036, Spain

Location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital de Jaén

Jaén, Jaén, 23007, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• José Luís González Larriba, MD

  SOGUG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: December 18, 2014

Record last verified: 2007-11

Locations

ES (7)