Epoetin Beta in Patients Undergoing Chemotherapy for Solid Tumors
Conditions
Anemia - Unspecified Adult Solid Tumor, Protocol Specific
Conditions: Keywords
anemia, unspecified adult solid tumor, protocol specific
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Intervention
Name: epoetin beta Type: Biological
Name: systemic chemotherapy Type: Drug
Name: quality-of-life assessment Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Diagnosis of solid tumor

- Hemoglobin 9-11 g/dL

- Planning to receive epoetin beta for ≥ 8 weeks while undergoing chemotherapy for cancer

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Not pregnant or nursing

- Not incarcerated or under guardianship

- No psychological, familial, social, or geographical reason that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 6 months since prior epoetin

- No concurrent chemoradiotherapy
Location
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Damien Pouessel, MD - 33-4-6761-3545
Start Date
December 2007
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page