The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment safety profile for these patients in second-line treatment with pazopanib. The exploratory aim is to determine the correlation between biomarkers in patient blood and tumor samples, and the clinical results obtained with pazopanib.
Patients who progress or do not tolerate a first-line treatment with a Tyrosine Kinase Inhibitor will be included consecutively in the study. All patients will receive the same treatment regimen consisting of 800 mg / day of pazopanib in monotherapy. All patients will receive treatment until there is evidence of progression, evidence of unacceptable toxicity, not compliance, investigator clinical decision or consent withdrawal by the patient. After treatment, the patient will enter to the follow-up period. During this period the investigator will collect information from subsequent administered treatments and survival of all patients, regardless of the reason for withdrawal, every 8 weeks until the scheduled end of follow-up period, according to protocol. At 30 days after treatment completion, the first follow up visit will be scheduled to assess the possible occurrence of late toxicity. In those patients who complete treatment prior to objectify progression, information about the progression of the disease will be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
800 mg / day of pazopanib in monotherapy.
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Objective Response Rate
To asses the Objective Response (Complete Response or Partial Response) which provides second-line treatment with pazopanib in patients with carcinoma of advanced renal cell who have progressed or have not tolerated a first line of treatment with a Tyrosine Kinase Inhibitor. The Objective Response Rate will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 30 months
Overall Survival
To assess the overall survival in patients treated with second-line treatment with pazopanib.
Time frame: 30 months
Treatment Safety Profile
To assess the treatment safety profile in patients treated with second-line treatment with pazopanib. Safety was assessed using Common Toxicity Criteria (CTC) of the National Cancer Institute (NCI), version 4.0.
Time frame: 30 months
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Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain