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

October 28, 2010 updated by: University of Turin, Italy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Turin
      • Orbassano (To), Turin, Italy, 10043
        • Recruiting
        • Alfredo Berruti
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced renal cells carcinoma and hepatocarcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sofanenib and Hypophosphatemia
Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib
Drug: Sorafenib
Sorafenib 800mg/die oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
Time Frame: one year
Assess the effects of sorafenib hormones involved in phosphate homeostasis
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify metabolic differences between renal cells cancer and hepatocarcinoma
Time Frame: one year
identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.
one year
Identify variations on bone mass during sorafenib treatment
Time Frame: one year
Assess Sorafenib effects on bone density and the relationship with phosphate related hormones
one year
Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability
Time Frame: one year
Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity).
one year
Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 662010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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