A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy. - Full Text View

Sponsored by:	Ortho Biotech Products, L.P.
Information provided by:	Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:	NCT00350090

Purpose

The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.

Condition	Intervention	Phase
Neoplasms Anemia	Drug: Epoetin Alfa	Phase III

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy

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

Primary Outcome Measures:

Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.

Secondary Outcome Measures:

Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.

Estimated Enrollment:	100
Study Start Date:	May 2003
Study Completion Date:	March 2004

Detailed Description:

This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study.

Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of non-myeloid malignancy
Baseline hemoglobin value of less than or equal to 11 g/dL unrelated to transfusion
Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
Female patients with reproductive potential must have a negative serum pregnancy test at screening

Exclusion Criteria:

Uncontrolled hypertension
History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
Transfusion within 28 days prior to first dose
Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350090

Sponsors and Collaborators

Ortho Biotech Products, L.P.

Investigators

Study Director:

Ortho Biotech Products, L.P. Clinical Trial

Ortho Biotech, Inc.

More Information

A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy or Radiation Therapy This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ This link exits the ClinicalTrials.gov site

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications of Results:

Shasha D, Williams D. Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy. J Support Oncol. 2006 Mar;4(3):129-35.

Study ID Numbers:	CR005113
Study First Received:	July 7, 2006
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00350090
Health Authority:	United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:

Anemia
Neoplasms
Hemoglobin values

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Neoplasms
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009