Kidney Cancer, Liver Cancer
Conditions
Keywords
Advanced, hepatocarcinoma
Brief summary
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
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.
Interventions
DRUGSorafenib
Sorafenib 800mg/die oral
Sponsors
University of Turin, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age over 18 years 2. Histologically documented kidney cancer or hepatocarcinoma 3. Performance status more than / equal to 2 4. Life expectancy \> 12 weeks 5. in patients with recent surgery, the wound should be completely healed before taking Sorafenib 6. 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) 7. Appropriate patienty compliance
Exclusion criteria
1. 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, 2. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated, 3. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent 4. Sintomatic brain metastases 5. 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 6. patients with seizures that need medical treatment 7. History of heterologous transplantation 8. Patients with previous or active bleeding 9. Dialysis patients 10. Patients with history of primary hyperparathyroidism 11. Dysphagic patients 12. Taking more than four weeks of entry into the study of other bio-chemotherapy treatments 13. Previous treatment with Sorafenib 14. Recent (\<6 months)or concomitant treatment with biphosphonate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration | one year | Assess the effects of sorafenib hormones involved in phosphate homeostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify metabolic differences between renal cells cancer and hepatocarcinoma | one year | identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma. |
| Identify variations on bone mass during sorafenib treatment | one year | Assess Sorafenib effects on bone density and the relationship with phosphate related hormones |
| Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability | one year | Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity). |
| Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival) | one year | — |
Countries
Italy
Outcome results
None listed