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

NCT ID: NCT00212862

Last Updated: 2014-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2009-07-31

Brief 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).

Detailed 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.

Conditions

Anemia; Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with chemotherapy induced anemia

Patients with chemotherapy induced anemia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Products, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ortho Biotech Products, L.P. Clinical Trial

Role: STUDY_DIRECTOR

Ortho Biotech Products, L.P.

References

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):159-67. doi: 10.2165/00044011-200828030-00003.

Reference Type: RESULT

PMID: 18266401 (View on PubMed)

Other Identifiers

ABT-OP-03-02

Identifier Type: OTHER

Identifier Source: secondary_id

CR004561

Identifier Type: -

Identifier Source: org_study_id