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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01230697
First received: September 2, 2010
Last updated: October 28, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Kidney Cancer
Liver Cancer
Drug: Sorafenib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration [ Time Frame: one year ] [ Designated as safety issue: No ]
    Assess the effects of sorafenib hormones involved in phosphate homeostasis


Secondary Outcome Measures:
  • Identify metabolic differences between renal cells cancer and hepatocarcinoma [ Time Frame: one year ] [ Designated as safety issue: No ]
    identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.

  • Identify variations on bone mass during sorafenib treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity).

  • Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival) [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum analites involved in phosphate homeostasis


Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: September 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sofanenib and Hypophosphatemia
Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib
Drug: Sorafenib
Sorafenib 800mg/die oral

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with advanced renal cells carcinoma and hepatocarcinoma

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230697

Locations
Italy
Alfredo Berruti Recruiting
Orbassano (To), Turin, Italy, 10043
Contact: Elisa Bellini, MD    (+39) 011 9026 ext 526    elisa.bellini3@tin.it   
Principal Investigator: Alfredo Berruti, PHD         
Sub-Investigator: Isabella Chiappino, MD         
Sub-Investigator: Cinzia Ortega, MD         
Sub-Investigator: Mario Pirisi, PHD         
Sub-Investigator: Antonino Picciotto, PHD         
Sub-Investigator: Camillo Porta, MD         
Sub-Investigator: Anna Pia, MD         
Sub-Investigator: Elena Bianco, MD         
Sponsors and Collaborators
University of Turin, Italy
  More Information

No publications provided

Responsible Party: Alfredo Berruti, Dipartimento di Scienze Cliniche e Biologiche - Università di Torino
ClinicalTrials.gov Identifier: NCT01230697     History of Changes
Other Study ID Numbers: 662010
Study First Received: September 2, 2010
Last Updated: October 28, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Turin, Italy:
Advanced
hepatocarcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Kidney Neoplasms
Liver Neoplasms
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Kidney Diseases
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014