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

NCT01230697 | Unknown DMC

• 1 other identifier: 662010
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer; Liver Cancer

Keywords

Advanced; hepatocarcinoma

Outcome Measures

Primary Outcomes (1)

• Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration

  Assess the effects of sorafenib hormones involved in phosphate homeostasis

  one year

Secondary Outcomes (4)

• Identify metabolic differences between renal cells cancer and hepatocarcinoma

  one year

• Identify variations on bone mass during sorafenib treatment

  one year

• Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability

  one year

• Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)

  one year

Study Arms (1)

Sofanenib and Hypophosphatemia

Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib

Drug: Sorafenib

Interventions

Sorafenib DRUG

Sorafenib 800mg/die oral

Sofanenib and Hypophosphatemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced renal cells carcinoma and hepatocarcinoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Alfredo Berruti

Orbassano (To), Turin, 10043, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum analites involved in phosphate homeostasis

MeSH Terms

Conditions

Kidney Neoplasms; Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: October 29, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2011
• Last Updated: October 29, 2010

Record last verified: 2010-07

Locations

IT (1)