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

Liver Cancer Clinical Trial

— SORHORM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01230697
• Other study ID #: 662010
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2010
• Last updated: October 28, 2010
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2010
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Carcinoma, Renal Cell
• Kidney Cancer
• Liver Cancer

Intervention

Drug:
• Sorafenib
Sorafenib 800mg/die oral

Locations

Country	Name	City	State
Italy	Alfredo Berruti	Orbassano (To)	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Identify metabolic differences between renal cells cancer and hepatocarcinoma	identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.	one year	No
Secondary	Identify variations on bone mass during sorafenib treatment	Assess Sorafenib effects on bone density and the relationship with phosphate related hormones	one year	No
Secondary	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	Yes
Secondary	Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)		one year	No