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Trial Title:
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)
NCT ID:
NCT01230697
Condition:
Kidney Cancer
Liver Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Kidney Neoplasms
Sorafenib
Conditions: Keywords:
Advanced
hepatocarcinoma
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Sorafenib
Description:
Sorafenib 800mg/die oral
Arm group label:
Sofanenib and Hypophosphatemia
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.
Criteria for eligibility:
Study pop:
Patients with advanced renal cells carcinoma and hepatocarcinoma
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alfredo Berruti
Address:
City:
Orbassano (To)
Zip:
10043
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa Bellini, MD
Phone:
(+39) 011 9026
Phone ext:
526
Email:
elisa.bellini3@tin.it
Investigator:
Last name:
Alfredo Berruti, PHD
Email:
Principal Investigator
Investigator:
Last name:
Isabella Chiappino, MD
Email:
Sub-Investigator
Investigator:
Last name:
Cinzia Ortega, MD
Email:
Sub-Investigator
Investigator:
Last name:
Mario Pirisi, PHD
Email:
Sub-Investigator
Investigator:
Last name:
Antonino Picciotto, PHD
Email:
Sub-Investigator
Investigator:
Last name:
Camillo Porta, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anna Pia, MD
Email:
Sub-Investigator
Investigator:
Last name:
Elena Bianco, MD
Email:
Sub-Investigator
Start date:
June 2010
Completion date:
September 2011
Lead sponsor:
Agency:
University of Turin, Italy
Agency class:
Other
Source:
University of Turin, Italy
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01230697
