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

Amgen300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Anemia Non-Myeloid Malignancies

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: baseline

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

Time frame: week 1, week 9, week 17

Secondary Outcomes

Estimates of the sensitivity and specificity of the FCST

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

Time frame: from baseline to end of treatment phase

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

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

Hgb improvement (defined as correction and/or response)

Time frame: from baseline to any point during the study

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

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

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

Time frame: throughout the study

Safety of darbepoetin alfa as determined by antibody formation

Time frame: throughout the study

Changes in concomitant medications

Time frame: throughout the study

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

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