Cost Effectiveness Of Sunitinib In Central America And Caribbean

Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean

Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries

Study Overview

• Status: Terminated
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: Sunitinib

Detailed Description

This study was terminated on 03Feb2011 due to the fact that the anticipated number of patients expected was not reached. The date of cessation of the drug was January 27, 2011. There was no intervention in the treatment or administration of the drug; the study only observed the treatment and collected data. As the study was dependent on the arrival of new patients with metastatic renal cancer, which was of a very low incidence, the study was terminated. Efficacy, adverse events or other safety issues were not factors in terminating the study. Lack of patients was the only reason.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Panama
  • Panama City, Panama
    • Pfizer Investigational Site

Participation Criteria

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

Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-α or Bevacizumab + IFN must be a joint decision made by the subject and the investigator. The investigator must discuss product information with the subject as per usual practice.

Description

Inclusion Criteria:

• Evidence of a personally signed (or legally acceptable representative) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
• Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated with Sutent, IFN-α or Bevacizumab + IFN ; on the selected institutions.

Exclusion Criteria:

• Adult men or women with RCCm treated with any other medication that is not Sutent, IFN-α or Bevacizumab + IFN.
• Adult men or women with mRCC with palliative care.
• Adult men or women with RCC without metastasis.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Central America and Caribbean; Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago	Drug: Sunitinib; Treatment for mRCC as indication approved and physician criterium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients that present metastasis when consulting for first time	9 months
Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment	9 months
Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α	9 months
Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-α and in first-line treatment with Bevacizumab + IFN-α	9 months
Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN	9 months
Quality of life in patients using an approved quality questionnaire	9 months
Costs-benefit of each treatment	9 months
PFY (progression free years) with each treatment	9 months
LY (life years) with each treatment	9 months
QALYs (quality adjusted life years) with each treatment	9 months
ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment	9 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 15, 2009
• First Posted (Estimate): December 17, 2009

Study Record Updates

• Last Update Posted (Estimate): April 19, 2012
• Last Update Submitted That Met QC Criteria: April 17, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: cost effectiveness; Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181189