Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)

Study Overview
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Brief Summary
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The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.

Detailed Description
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Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown. Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.

Official Title
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Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib. Multicenter Cohort Study

Conditions
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Kidney Cancer, Liver Cancer

Intervention / Treatment
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* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years Histologically documented kidney cancer or hepatocarcinoma Performance status more than / equal to 2 Life expectancy > 12 weeks in patients with recent surgery, the wound should be completely healed before taking Sorafenib required initial laboratory values: absolute neutrophil count > 1500/ul Platelets > 100,000/ul., Hemoglobin > 9.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal Bilirubin less than/equal to upper limit of normal(ULN) Appropriate patienty compliance Exclusion Criteria: myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia, previous history of malignant disease with the exception of non melanoma skin cancer curatively treated, significant neurologic or psychiatric diseases preventing patients to give a valid informed consent Sintomatic brain metastases because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded patients with seizures that need medical treatment History of heterologous transplantation Patients with previous or active bleeding Dialysis patients Patients with history of primary hyperparathyroidism Dysphagic patients Taking more than four weeks of entry into the study of other bio-chemotherapy treatments Previous treatment with Sorafenib Recent (<6 months)or concomitant treatment with biphosphonate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sofanenib and Hypophosphatemia<br>Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib | Drug: Sorafenib<br>* Sorafenib 800mg/die oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration | Assess the effects of sorafenib hormones involved in phosphate homeostasis | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify metabolic differences between renal cells cancer and hepatocarcinoma | identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma. | one year | 
| Identify variations on bone mass during sorafenib treatment | Assess Sorafenib effects on bone density and the relationship with phosphate related hormones | one year | 
| Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability | Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity). | one year | 
| Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival) |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, hepatocarcinoma