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


N/A
18 Years
N/A
Open (Enrolling)
Both
Anemia, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Treatment failure (changes in hemoglobin levels)

Safety Issue:

No

Principal Investigator

Damien Pouessel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

Unspecified

Study ID:

CDR0000633325

NCT ID:

NCT00875004

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Anemia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • anemia
  • unspecified adult solid tumor, protocol specific
  • Anemia
  • Neoplasms

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