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

• Conditions: Kidney Cancer; Liver Cancer
• Interventions: Drug: Sorafenib

• Registration Number: NCT01230697
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2010-06
• Status Verified: 2010-07
• Primary Completion: 2010-08
• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-10-28
• Last Update Submitted: 2010-10-28
• Study First Posted: 2010-10-29
• Last Update Posted: 2010-10-29
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sofanenib and Hypophosphatemia	Sorafenib	Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)	one year
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).

Trial Locations

Locations (1)

Alfredo Berruti; 🇮🇹 Orbassano (To), Turin, Italy