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

NCT00540696 | Completed Phase 2

• 1 other identifier: 20000220
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Non-Myeloid Malignancies

Keywords

Anemia; Non-Myeloid Malignancies; darbepoetin alfa; chemotherapy

Outcome Measures

Primary Outcomes (2)

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

  baseline

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

  week 1, week 9, week 17

Secondary Outcomes (12)

• Estimates of the sensitivity and specificity of the FCST

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

  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

  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)

  from baseline to any point during the study

• Hgb improvement (defined as correction and/or response)

  from baseline to any point during the study

Study Arms (1)

darbepoetin alfa

EXPERIMENTAL

Drug: darbepoetin alfa

Interventions

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.

darbepoetin alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• 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.

  PMID: 15352656 RESULT

• 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.

  PMID: 16411031 RESULT

• 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.

  PMID: 18642348 RESULT

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: September 1, 2001
• Primary Completion: June 1, 2003
• Study Completion: September 1, 2003
• Last Updated: April 26, 2013

Record last verified: 2013-04