Cost Effectiveness Of Sunitinib In Central America And Caribbean

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01033981
First received: December 14, 2009
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Rate of patients that present metastasis when consulting for first time [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Quality of life in patients using an approved quality questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Costs-benefit of each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • PFY (progression free years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • LY (life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • QALYs (quality adjusted life years) with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Central America and Caribbean
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago
Drug: Sunitinib
Treatment for mRCC as indication approved and physician criterium

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.

  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

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033981

Locations
Panama
Pfizer Investigational Site
Panama City, Panama
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01033981     History of Changes
Other Study ID Numbers: A6181189
Study First Received: December 14, 2009
Last Updated: April 17, 2012
Health Authority: Costa Rica: Centro de Desarrollo Estratégico e Información en Salud y Seguridad Social (CENDEISSS)

Keywords provided by Pfizer:
cost effectiveness
Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014