Back to resultsEpoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors (PLATON)
Primary Purpose
Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
epoetin beta
systemic chemotherapy
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Anemia focused on measuring anemia, unspecified adult solid tumor, protocol specific
Eligibility Criteria
Inclusion criteria :
- Age > 18 years
- Hemoglobin levels between [ > 9g/dl - < 11 g/dl ] .
- Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
- Patient with cancer undergoing chemotherapy
- Patient without EPO within 6 months prior to current chemotherapy.
- WHO 2 performance status (Appendix 1).
- Patient information and signature of informed consent or legal representative
Exclusion criteria :
- Hemoglobin < 9 g/dl or > 11 g/dl
- Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)
- Patient with cancer treated with concomitant radiation chemotherapy.
- Co-treated with Epo beta and scheduled transfusion prior to inclusion.
- Hypersensitivity to the active substance or one of the NeoRecormon excipients®
- Poorly controlled high blood pressure
- Pregnant woman, likely to be pregnant or breastfeeding,
- Persons deprived of liberty or under guardianship,
- Unable to undergo medical follow-up for geographic, social or psychological reasons.
Sites / Locations
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erythropoietin beta
Arm Description
Outcomes
Primary Outcome Measures
Treatment failure (changes in hemoglobin levels)
The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success
Secondary Outcome Measures
Full Information
NCT ID
NCT00875004
First Posted
April 2, 2009
Last Updated
August 12, 2022
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT00875004
Brief Title
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Acronym
PLATON
Official Title
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
After two years of trial initiation, only 27 out of 300 patients were included. During this period, the international recommendations for the use of COOL were modified.
Study Start Date
December 7, 2007 (Actual)
Primary Completion Date
December 31, 2011 (Actual)
Study Completion Date
December 31, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.
PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.
Detailed Description
OBJECTIVES:
Primary
Identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy.
Secondary
Evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin > 11 g/dL) after 8 weeks of treatment with epoetin beta.
Evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta.
Evaluate the tolerability of epoetin beta in these patients.
Evaluate the quality of life of these patients.
OUTLINE: This is a multicenter study.
Patients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire (FACT-An) at baseline and after 8 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
anemia, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erythropoietin beta
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
epoetin beta
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Treatment failure (changes in hemoglobin levels)
Description
The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success
Time Frame
From date of randomization until the week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Age > 18 years
Hemoglobin levels between [ > 9g/dl - < 11 g/dl ] .
Patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol.
Patient with cancer undergoing chemotherapy
Patient without EPO within 6 months prior to current chemotherapy.
WHO 2 performance status (Appendix 1).
Patient information and signature of informed consent or legal representative
Exclusion criteria :
Hemoglobin < 9 g/dl or > 11 g/dl
Patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc…)
Patient with cancer treated with concomitant radiation chemotherapy.
Co-treated with Epo beta and scheduled transfusion prior to inclusion.
Hypersensitivity to the active substance or one of the NeoRecormon excipients®
Poorly controlled high blood pressure
Pregnant woman, likely to be pregnant or breastfeeding,
Persons deprived of liberty or under guardianship,
Unable to undergo medical follow-up for geographic, social or psychological reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien Pouessel, MD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
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