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Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Phase 4
18 Years
Not Enrolling
Anemia, Cancer

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Trial Information

Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a
prospective, observational multicenter registry of approximately 1200 adult cancer patients
receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration
of the DOSE Registry is three years. Based on initial results, the registry sponsor may
elect to extend the duration of the registry.This study does not specify treatment
protocols, require any particular assignment of patients to treatment protocols, or in any
other way require participating physicians to alter their practice patterns. Participating
physicians are instructed to continue to treat all patients according to their own best
clinical judgment, but to submit information on baseline patient characteristics, treatment
patterns, and clinical outcomes. Baseline determinations will include patient demographics,
tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will
be collected over the 16-week study period with regard to EST treatment, hematologic
outcomes and patient reported outcomes.

Inclusion Criteria:

- Patients with cancer who are being treated with an erythropoiesis-stimulating therapy
(EST) for anemia of cancer or cancer-related treatment

- Must be EST ''naive'' globally or must have been off treatment with an EST for at
least 90 days

- Must speak and read english and be able to answer the type of simple questions
presented in the patient questionnaires

- If the patient is identified for the study while an inpatient, they must be able to
be followed for up to 16 weeks

- The patient must give consent to participate in the registry by signing the informed
consent form

Exclusion Criteria:

- Patients currently participating in any other clinical study of EST (however, the
patient may be undergoing treatment under an investigational cancer treatment

- Have or had been on dialysis for end stage renal disease in the past

- Has myelodysplasia or any myelodysplastic syndrome

- Patients are known to need stem cell transplant

- Patient who will self-administer the epoetin alfa or darbepoetin alfa

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To document patient characteristics and patterns of clinical management

Outcome Description:

The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Ortho Biotech Products, L.P. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Ortho Biotech Products, L.P.


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

July 2009

Related Keywords:

  • Anemia
  • Cancer
  • Anemia
  • Cancer
  • Epoetin alfa
  • Darbepoetin alfa
  • Registry
  • Anemia