The Duration Study - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Ortho Biotech Products, L.P.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00210730

Purpose

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in patients with cancer who are anemic.

Condition	Intervention	Phase
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, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT®) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.

Secondary Outcome Measures:

Proportion of patients transfused, time to first transfusion, proportion of patients with two post baseline Hb values > 12 g/dL, mean final Hb, mean lowest Hb, proportion of patients with Hb < 10, weekly Hb, QOL

Estimated Enrollment:	252
Study Start Date:	June 2004
Study Completion Date:	July 2005

Detailed Description:

The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after completion of chemotherapy administration as compared to patients who do not receive weekly epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin alfa (PROCRIT®) treatment control (whereby patients in the control group will receive epoetin alfa (PROCRIT®) if their Hb decreases to < 10g/dL during the study) will be used to establish the frequency and magnitude of changes in clinical end points that may occur when epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be used to give every patient a greater chance to receive immediate treatment (66.6% epoetin alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The study will be powered to show differences between the two groups in hematologic response. In this study, the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at >= 11 g/dL during the study without a Hb drop to <= 10 g/dL and/or transfusion. The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in patients with cancer and persistent chemotherapy-induced anemia.

Patients will be randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be 40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units QW). If the Hb level decreases to <= 10 g/dL, PROCRIT will be initiated at a dose of 40,000 Units QW.

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 >= 11 g/dL and <= 12 g/dL unrelated to transfusion
Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent

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 myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210730

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

An open label, randomized study to evaluate the response rate of PROCRIT (Epoetin alfa) versus no/delayed PROCRIT treatment in patients with cancer and persistent chemotherapy-induced myelosuppression (anemia). This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR004591
Study First Received:	September 13, 2005
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00210730
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Anemia
Hemoglobin Level
Neoplasm

Study placed in the following topic categories:

Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009