Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia

Cancer Clinical Trial

— DOSE  

Official title:

Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212862
• Other study ID #: CR004561
• Secondary ID: ABT-OP-03-02
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: June 27, 2014
• Start date: December 2003
• Est. completion date: July 2009

Study information

• Verified date: June 2014
• Source: Ortho Biotech Products, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2130
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 protocol)

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Cancer

Intervention

Other:
• Patients with chemotherapy induced anemia
Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho Biotech Products, L.P.

References & Publications (1)

Larholt K, Pashos CL, Wang Q, Bookhart B, McKenzie RS, Piech CT. Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (DOSE) : a registry for characterizing anaemia management and outcomes in oncology patients. Clin Drug Investig. 2008;28(3): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document patient characteristics and patterns of clinical management	The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.	Up to 3 years	No
Secondary	To assess the relationships between patient characteristics, treatment patterns and outcomes		Up to 3 years	No
Secondary	To measure economic impacts, and quality of life		Up to 3 years	No