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

Purpose

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.

Condition	Intervention	Phase
Anemia Non-Myeloid Malignancies	Drug: darbepoetin alfa	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score [ Time Frame: baseline ] [ Designated as safety issue: No ]
Relationship between hemoglobin (hgb) response and change in functional capacity [ Time Frame: week 1, week 9, week 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Estimates of the sensitivity and specificity of the FCST [ Designated as safety issue: No ]
Relationship between hgb variables and changes on the MHST score, the FCST and its components [ Time Frame: from baseline to end of treatment phase ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Hgb improvement (defined as correction and/or response) [ Time Frame: from baseline to any point during the study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Safety of this dosing regimen of darbepoetin alfa by incidence of clinical adverse events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Safety of darbepoetin alfa as determined by antibody formation [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Changes in concomitant medications [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2001
Study Completion Date:	September 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: darbepoetin alfa	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540696

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00540696 History of Changes
Other Study ID Numbers:	20000220
Study First Received:	October 4, 2007
Last Updated:	April 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Anemia
Non-Myeloid Malignancies
darbepoetin alfa
chemotherapy

Additional relevant MeSH terms:

Anemia
Neoplasms
Hematologic Diseases
Darbepoetin alfa

Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013