Cost Effectiveness Of Sunitinib In Central America And Caribbean

Terminated

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Sunitinib

• Registration Number: NCT01033981
• Lead Sponsor: Pfizer

Brief Summary

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

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 Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-17
• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-17
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Central America and Caribbean	Sunitinib	Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad \& Tobago

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇦 Panama City, Panama