Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (D.O.S.E. Registry)

Condition(s) targeted: Anemia; Darbepoetin Alfa; Cancer; Epoetin Alfa

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Ortho Biotech Products, L.P.

Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech Products, L.P.

The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST; i. e. epoetin alfa or darbepoetin alfa)

Official title: Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Study design: Prospective

Detailed description: DOSE is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with epoetin alfa or darbepoetin alfa. 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.

N/A

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults (18 years of age or older) with cancer who are being treated with an

erythropoiesis-stimulating therapy for anemia of cancer or cancer-related treatment

- The patient must speak and read English and be able to answer the type of simple

questions presented in the patient questionnaires

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

consent form

Exclusion Criteria:

- No epoetin alfa or darbepoetin alfa within 90 days prior to study entry

- Not currently participating in any other clinical study of EST (however, the patient

may be undergoing treatment under an investigational cancer treatment protocol)

- No current or previous history of dialysis for end stage renal disease

- No known myelodysplasia or any myelodysplastic syndrome

- Not known to need stem cell transplant

- No self-administration of epoetin alfa or darbepoetin alfa

Last updated: June 12, 2008