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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anemia Non-Myeloid Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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darbepoetin alfa

Group Type EXPERIMENTAL

darbepoetin alfa

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No