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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00350090
Recruitment Status : Terminated (This study was stopped early due to slow enrollment.)
First Posted : July 10, 2006
Last Update Posted : May 19, 2011
Information provided by:
Ortho Biotech Products, L.P.

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Neoplasms Drug: Epoetin Alfa Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2002
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00350090

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

Additional Information:
Publications of Results: Identifier: NCT00350090     History of Changes
Other Study ID Numbers: CR005113
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: March 2010

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

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa