Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors

Not Applicable

Terminated

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Anemia
• Interventions: Biological: epoetin beta; Drug: systemic chemotherapy; Procedure: quality-of-life assessment

• Registration Number: NCT00875004
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Timeline

• Study Start: 2007-12-07
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Primary Completion: 2011-12-31
• Study Completion: 2011-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erythropoietin beta	quality-of-life assessment	-
Erythropoietin beta	systemic chemotherapy	-
Erythropoietin beta	epoetin beta	-

Primary Outcome Measures

Name	Time	Method
Treatment failure (changes in hemoglobin levels)	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

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France