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

Anemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540696
• Other study ID #: 20000220
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2007
• Last updated: April 24, 2013
• Start date: September 2001
• Est. completion date: September 2003

Study information

• Verified date: April 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms
• Non-Myeloid Malignancies

Intervention

Drug:
• darbepoetin alfa
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (3)

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/ — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score		baseline	No
Primary	Relationship between hemoglobin (hgb) response and change in functional capacity		week 1, week 9, week 17	No
Secondary	Estimates of the sensitivity and specificity of the FCST			No
Secondary	Relationship between hgb variables and changes on the MHST score, the FCST and its components		from baseline to end of treatment phase	No
Secondary	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		from baseline to any point during the study	No
Secondary	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)		from baseline to any point during the study	No
Secondary	Hgb improvement (defined as correction and/or response)		from baseline to any point during the study	No
Secondary	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		from baseline to week 17	No
Secondary	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		from weeks 1 to end of treatment phase, weeks 1 to 4, and weeks 5 to end of treatment phase	No
Secondary	Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events		throughout the study	Yes
Secondary	Safety of darbepoetin alfa as determined by antibody formation		throughout the study	Yes
Secondary	Changes in concomitant medications		throughout the study	Yes
Secondary	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)		within a 28-day window during the treatment period	Yes
Secondary	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)		at any point during the study	Yes

External Links

•   AmgenTrials clinical trials website