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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00212862
First received: September 13, 2005
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Anemia
Cancer
Other: Patients with chemotherapy induced anemia
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

Resource links provided by NLM:


Further study details as provided by Ortho Biotech Products, L.P.:

Primary Outcome Measures:
  • To document patient characteristics and patterns of clinical management [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.


Secondary Outcome Measures:
  • To assess the relationships between patient characteristics, treatment patterns and outcomes [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • To measure economic impacts, and quality of life [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 2130
Study Start Date: December 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with chemotherapy induced anemia 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212862

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
  More Information

Publications:
Responsible Party: Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier: NCT00212862     History of Changes
Other Study ID Numbers: CR004561, ABT-OP-03-02
Study First Received: September 13, 2005
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho Biotech Products, L.P.:
Anemia
Cancer
Epoetin alfa
Darbepoetin alfa
Registry

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014