Status:
UNKNOWN
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)
Lead Sponsor:
University of Turin, Italy
Conditions:
Kidney Cancer
Liver Cancer
Eligibility:
All Genders
18+ years
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 disturba...
Eligibility Criteria
Inclusion
- age over 18 years
- Histologically documented kidney cancer or hepatocarcinoma
- Performance status more than / equal to 2
- Life expectancy \> 12 weeks
- in patients with recent surgery, the wound should be completely healed before taking Sorafenib
- 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)
- Appropriate patienty compliance
Exclusion
- 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,
- previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
- Sintomatic brain metastases
- 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
- patients with seizures that need medical treatment
- History of heterologous transplantation
- Patients with previous or active bleeding
- Dialysis patients
- Patients with history of primary hyperparathyroidism
- Dysphagic patients
- Taking more than four weeks of entry into the study of other bio-chemotherapy treatments
- Previous treatment with Sorafenib
- Recent (\<6 months)or concomitant treatment with biphosphonate
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01230697
Start Date
June 1 2010
End Date
September 1 2011
Last Update
October 29 2010
Active Locations (1)
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1
Alfredo Berruti
Orbassano (To), Turin, Italy, 10043