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

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Turin, Italy
• Treatments: Hormones; Niacinamide; Sorafenib

Criteria

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