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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer, Liver Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration

Outcome Description:

Assess the effects of sorafenib hormones involved in phosphate homeostasis

Outcome Time Frame:

one year

Safety Issue:

No

Authority:

Italy: The Italian Medicines Agency

Study ID:

662010

NCT ID:

NCT01230697

Start Date:

June 2010

Completion Date:

September 2011

Related Keywords:

  • Kidney Cancer
  • Liver Cancer
  • Advanced
  • hepatocarcinoma
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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