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
Recruitment status was Recruiting
Sponsor:
University of Turin, Italy
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
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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:
- 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 Criteria:
- 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
Contacts and Locations
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, Renal Cell Kidney Neoplasms Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013