title: Rationale and protocol of SOAP: a phase II study to evaluate the efficacy of sorafenib as second-line treatment after pazopanib in patients with advanced renal cell carcinoma.
abstract: The introduction of agents targeting vascular endothelial grow factors has radically changed the approach to metastatic renal cell carcinoma; however, cure is not within definitive reach. In many cases, the tumor will progress several months after the start of first-line therapy and new lines of therapy are required. Pazopanib and sorafenib are two frequently used targeted agents, and no sound data are currently available for patients who relapsed after pazopanib. In this paper we illustrate the SOAP study, which was designed to evaluate the safety and efficacy of sorafenib in terms of progression free-survival in 44 patients treated in 10 Italian centers who had relapsed after first-line pazopanib. Standard treatment with sorafenib will be administered until disease progression or unacceptable toxicity. Secondary endpoints include the evaluation of overall survival, safety and quality of life. A subanalysis to evaluate toxicities as predictive factors has also been planned.
authors: Roberto
authors: R
authors: Iacovelli
authors: Elena
authors: E
authors: Verzoni
authors: Paolo
authors: P
authors: Grassi
authors: Alessio
authors: A
authors: Farcomeni
authors: Filippo
authors: F
authors: de Braud
authors: Giuseppe
authors: G
authors: Procopio
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000284:Administration, Oral; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D017322:Clinical Trials, Phase II as Topic; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D007191:Indazoles; D007558:Italy; D007680:Kidney Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D058990:Molecular Targeted Therapy / Q000379:methods; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011743:Pyrimidines / Q000627:therapeutic use; D011788:Quality of Life; D040262:Receptors, Vascular Endothelial Growth Factor / Q000037:antagonists & inhibitors; D012107:Research Design; D000077157:Sorafenib; D013449:Sulfonamides / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome; D015337:Multicenter Studies as Topic
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007191:Indazoles; D009536:Niacinamide; C516667:pazopanib; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D040262:Receptors, Vascular Endothelial Growth Factor; D000077157:Sorafenib; D013449:Sulfonamides