Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-29 @ 4:06 AM
Study NCT ID:
NCT00875004
Status:
TERMINATED
Last Update Posted:
2024-06-26
First Post:
2009-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Organization:
Study Overview
Official Title:
Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormonĀ®) in Patients With Solid Tumors Treated With Chemotherapy
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATON
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.
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 ā„ 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.
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 ā„ 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: