AnemiaPLATONNCT00875004

Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

A study testing epoetin beta, systemic chemotherapy and quality-of-life assessment in people with Anemia and Unspecified Adult Solid Tumor, Protocol Specific, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Anemia, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: epoetin beta, systemic chemotherapy and quality-of-life assessment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteFrance
Study dates: 7 Dec 2007to 31 Dec 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

France1 site

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

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions: Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Being tested: epoetin beta, systemic chemotherapy, quality-of-life assessment
Keywords: anemia, unspecified adult solid tumor, protocol specific
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

epoetin betaBiological
systemic chemotherapyDrug
quality-of-life assessmentProcedure or surgery

Study groups in NCT00875004
Study group	Role	What they receive
Erythropoietin beta	Experimental	Not described Receives: Biological: epoetin beta; Drug: systemic chemotherapy; Procedure: quality-of-life assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 200731 Dec 2011

First posted3 Apr 2009 (estimated)
Study start7 Dec 2007
Primary completion31 Dec 2011
Study completion31 Dec 2011

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875004
Sponsor's protocol ID: CDR0000633325
Other IDs: CLCC-VA-2007/21, CLCC-AFSSAPS-A70755-52, INCA-RECF0639, EUDRACT-2007-003615-31, ROCHE-CLCC-PLATON
Acronym: PLATON
Status last verified: Aug 2022
First submitted: 2 Apr 2009
Last updated: 26 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Beguin Y. Prediction of response to treatment with recombinant human erythropoietin in anaemia associated with cancer. Med Oncol. 1998 Aug;15 Suppl 1:S38-46.
PubMed 9785336
Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. doi: 10.1016/j.ejca.2004.07.015.
PubMed 15454245
Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915.
PubMed 8763799
Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9.
PubMed 9253779
Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
PubMed 11040270
Del Mastro L, Gennari A, Donati S. Chemotherapy of non-small-cell lung cancer: role of erythropoietin in the management of anemia. Ann Oncol. 1999;10 Suppl 5:S91-4. doi: 10.1093/annonc/10.suppl_5.s91.
PubMed 10582148
Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):3412-25. doi: 10.1200/JCO.1998.16.10.3412.
PubMed 9779721
Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997 Mar;15(3):1218-34. doi: 10.1200/JCO.1997.15.3.1218.
PubMed 9060566
Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999 Oct 6;91(19):1616-34. doi: 10.1093/jnci/91.19.1616.
PubMed 10511589
Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol. 2001 Apr;28(2 Suppl 8):49-53. doi: 10.1016/s0093-7754(01)90213-1.
PubMed 11395853
Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. doi: 10.1016/j.ejca.2006.10.014. Epub 2006 Dec 19.
PubMed 17182241
Aapro M, Coiffier B, Dunst J, Osterborg A, Burger HU. Effect of treatment with epoetin beta on short-term tumour progression and survival in anaemic patients with cancer: A meta-analysis. Br J Cancer. 2006 Dec 4;95(11):1467-73. doi: 10.1038/sj.bjc.6603481. Epub 2006 Nov 21.
PubMed 17117175
Oberhoff C. Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins. Support Care Cancer. 2007 Jun;15(6):603-611. doi: 10.1007/s00520-006-0191-x. Epub 2007 Feb 3.
PubMed 17277926
Pujade-Lauraine E, Topham C. Once-weekly treatment of anemia in patients with cancer: a comparative review of epoetins. Oncology. 2005;68(2-3):122-9. doi: 10.1159/000086957. Epub 2005 Jul 7.
PubMed 16015034
Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol. 1998 Jan;49(1):41-4.
PubMed 9491285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy
ClinicalTrials.gov ID: NCT00875004
Acronym / sponsor ID: PLATON / CDR0000633325
Conditions: Anemia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords: anemia, unspecified adult solid tumor, protocol specific
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 27 participants (actual)
Lead sponsor: Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
Study start: 7 Dec 2007 (actual)
Primary completion: 31 Dec 2011 (actual)
Study completion: 31 Dec 2011 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erythropoietin beta	Experimental	Biological: epoetin beta, Drug: systemic chemotherapy, Procedure: quality-of-life assessment

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (9 listed)

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®

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
epoetin beta	Biological	Erythropoietin beta
systemic chemotherapy	Drug	Erythropoietin beta
quality-of-life assessment	Procedure or surgery	Erythropoietin beta

Primary outcome

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

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
Background: PubMed 9785336Beguin Y. Prediction of response to treatment with recombinant human erythropoietin in anaemia associated with cancer. Med Oncol. 1998 Aug;15 Suppl 1:S38-46.
Background: PubMed 15454245Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. doi: 10.1016/j.ejca.2004.07.015.
Background: PubMed 8763799Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915.
Background: PubMed 9253779Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9.
Background: PubMed 11040270Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.
Background: PubMed 10582148Del Mastro L, Gennari A, Donati S. Chemotherapy of non-small-cell lung cancer: role of erythropoietin in the management of anemia. Ann Oncol. 1999;10 Suppl 5:S91-4. doi: 10.1093/annonc/10.suppl_5.s91.
Background: PubMed 9779721Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):3412-25. doi: 10.1200/JCO.1998.16.10.3412.
Background: PubMed 9060566Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997 Mar;15(3):1218-34. doi: 10.1200/JCO.1997.15.3.1218.
Background: PubMed 10511589Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999 Oct 6;91(19):1616-34. doi: 10.1093/jnci/91.19.1616.
Background: PubMed 11395853Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol. 2001 Apr;28(2 Suppl 8):49-53. doi: 10.1016/s0093-7754(01)90213-1.
Background: PubMed 17182241Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. doi: 10.1016/j.ejca.2006.10.014. Epub 2006 Dec 19.
Background: PubMed 17117175Aapro M, Coiffier B, Dunst J, Osterborg A, Burger HU. Effect of treatment with epoetin beta on short-term tumour progression and survival in anaemic patients with cancer: A meta-analysis. Br J Cancer. 2006 Dec 4;95(11):1467-73. doi: 10.1038/sj.bjc.6603481. Epub 2006 Nov 21.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Damien Pouessel, MD principal investigator

Institut du Cancer de Montpellier - Val d'Aurelle

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (changes in hemoglobin levels) (time frame: From date of randomization until the week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875004, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.