Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors (PLATON)

August 12, 2022 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythropoietin beta
Procedure: quality-of-life assessment
Drug: systemic chemotherapy
Biological: epoetin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure (changes in hemoglobin levels)
Time Frame: From date of randomization until the week 8
The 8th week of treatment assessment defines the patient on erythropoeitine beta (NeoRecormon®) treatment for failure or success
From date of randomization until the week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Principal Investigator: Damien Pouessel, MD, Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2007

Primary Completion (Actual)

December 31, 2011

Study Completion (Actual)

December 31, 2011

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633325
  • CLCC-VA-2007/21
  • CLCC-AFSSAPS-A70755-52
  • INCA-RECF0639
  • EUDRACT-2007-003615-31
  • ROCHE-CLCC-PLATON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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