Clinical trial NCT00540696: Study to Develop a Screening Tool for Functional Capacity in Anemic Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Darbepoetin Alfa
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Non-Myeloid Malignancies
Keywords: Anemia
Non-Myeloid Malignancies
darbepoetin alfa
chemotherapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score
timeFrame: baseline
measure: Relationship between hemoglobin (hgb) response and change in functional capacity
timeFrame: week 1, week 9, week 17
Secondary outcomes:
measure: Estimates of the sensitivity and specificity of the FCST
measure: Relationship between hgb variables and changes on the MHST score, the FCST and its components
timeFrame: from baseline to end of treatment phase
measure: 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
timeFrame: from baseline to any point during the study
measure: 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)
timeFrame: from baseline to any point during the study
measure: Hgb improvement (defined as correction and/or response)
timeFrame: from baseline to any point during the study
measure: 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
timeFrame: from baseline to week 17
measure: 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
timeFrame: from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase
measure: Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events
timeFrame: throughout the study
measure: Safety of darbepoetin alfa as determined by antibody formation
timeFrame: throughout the study
measure: Changes in concomitant medications
timeFrame: throughout the study
measure: 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)
timeFrame: within a 28-day window during the treatment period
measure: 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)
timeFrame: at any point during the study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Vadhan-Raj S, Mirtsching B, Charu V, Terry D, Rossi G, Tomita D, McGuire WP. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol. 2003 Jul-Aug;1(2):131-8.
citation: Kallich J, McDermott A, Xu X, Fayers P, Cella D. The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res. 2006 Feb;15(1):57-68. doi: 10.1007/s11136-005-8324-0.
citation: Cella D, Viswanathan HN, Hays RD, Mendoza TR, Stein KD, Pasta DJ, Foreman AJ, Vadhan-Raj S, Kallich JD. Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy. Cancer. 2008 Sep 15;113(6):1480-8. doi: 10.1002/cncr.23698.