Skip to main content
OpenTrials
Completed

NCT Number: NCT00540696

Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa

The purpose of this study is to develop a functional capacity screening tool (FCST) that estimates at baseline the functional capacity of anemic subjects with nonmyeloid malignancies receiving multicycle chemotherapy.

Sites will be randomly assigned in 1:1 ratio to 1 of 2 different subject-reported functional capacity questionnaires. The questionnaires will be used to develop the FCST. Subjects will participate in the Modified Harvard Step Test (MHST) at required timepoints and receive darbepoetin alfa once every 2 weeks for 15 weeks. All subjects will return for a follow-up visit 2 weeks after the last dose of darbepoetin alfa.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Non-Myeloid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-myeloid malignancies
  • Anemia (hgb less than or equal to 11.0 g/dL) related to cancer and chemotherapy
  • Plan to receive cyclic chemotherapy for an additional 8 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate renal and liver function
  • Ability to participate in the MHST based on clinical judgement of investigator
  • At least 18 years of age

Exclusion criteria

  • Iron deficiency
  • Received recombinant human erythropoietin (rHuEPO) therapy within 4 weeks prior to enrollment
  • Unstable cardiac disease
  • Current active condition creating clinical danger for the subject to participate in the MHST
  • known positive test for HIV infection
  • Previous hematologic disorder associated with anemia
  • Currently receiving beta-blockers
  • Use of drugs or devices not approved by the FDA for any indication
  • Pregnant or breast feeding
  • Known hypersensitivity to any recombinant mammalian-derived product

Treatment and study plan

darbepoetin alfa

Drug

Darbepoetin alfa 3.0mcg/kg every 2 weeks for 3 doses. At week 7, if the subject has not experienced an increase of at least 1.0g/dL in hgb from week 1, increase dose of darbepoetin alfa to 5.0mcg/kg every 2 weeks for 5 doses.

Otherwise, maintain darbepoetin alfa 3.0mcg/kg every 2 weeks for 5 doses.

Primary outcomes

  1. Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score

    Time frame: baseline

  2. Relationship between hemoglobin (hgb) response and change in functional capacity

    Time frame: week 1, week 9, week 17

Secondary outcomes

  1. Estimates of the sensitivity and specificity of the FCST

  2. Relationship between hgb variables and changes on the MHST score, the FCST and its components

    Time frame: from baseline to end of treatment phase

  3. Maximum change in hgb from baseline to any point during the study, excluding hgb measurements obtained within 28 days of a red blood cell (RBC) transfusion

    Time frame: from baseline to any point during the study

  4. Number and proportion of subjects who achieve a hgb response as defined by an increase of greater than or equal to 2.0 g/dL from the baseline hgb in absence of any RBC transfusion within the prior 28 days at any point during the study (hgb response)

    Time frame: from baseline to any point during the study

  5. Hgb improvement (defined as correction and/or response)

    Time frame: from baseline to any point during the study

  6. Change in hgb from baseline to week 17, or the subject's last hgb value excluding hgb measurements obtained within 28 days of a RBC transfusion

    Time frame: from baseline to week 17

  7. Number and proportion of subjects who receive any RBC transfusions, the number of units of RBC transfused, and the number of days with at least 1 RBC transfusion from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase

    Time frame: from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase

  8. Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events

    Time frame: throughout the study

  9. Safety of darbepoetin alfa as determined by antibody formation

    Time frame: throughout the study

  10. Changes in concomitant medications

    Time frame: throughout the study

  11. Rapid rise in hgb (a greater than or equal to 2.0 g/dL increase in hgb concentration within a 28-day window during the treatment period)

    Time frame: within a 28-day window during the treatment period

  12. Proportion of subjects who achieve a hgb of greater than or equal to 12.0 g/dL at any point during the study (hgb correction)

    Time frame: at any point during the study

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-label, Randomized Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa (NESP)

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Oct 8, 2007
Registry last updated
Apr 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.