ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy

This study has been completed.

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: NCT00210600
  Purpose

The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).


Condition Intervention Phase
Anemia
Drug: PROCRIT (Epoetin alfa)
Phase II

MedlinePlus related topics:   Anemia   

ChemIDplus related topics:   Epoetin alfa    Erythropoietin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:   Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.

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

Primary Outcome Measures:
  • The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.

Secondary Outcome Measures:
  • The proportion of patients in the early intervention group for whom all hemoglobin values during the 16 week PROCRIT (Epoetin alfa) treatment were > 11.0 g/dL and < 13.0 g/dL.

Estimated Enrollment:   180
Study Start Date:   May 2005
Study Completion Date:   August 2006

Detailed Description:

This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy: 1.Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and 2.Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry. For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study.

All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.

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

Criteria

Inclusion Criteria:

  • Biopsy confirmed diagnosis of non-myeloid malignancy
  • Baseline hemoglobin (Hb) value of >= 11.0 g/dL and <= 12.0 g/dL
  • No blood transfusions in the 28 days prior to the start of Treatment Phase
  • Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
  • Iron transferrin saturation (TSAT) > 20% or if TSAT<20%, serum ferritin must be greater than 100 ng/mL

Exclusion Criteria:

  • No myeloid malignancy or known history of myelodysplasia
  • No planned radiation during the study
  • Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
  • No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
  • No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
  • Has not received an experimental drug or device within the past 30 days
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210600

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


Assessment of Early and Standard Intervention with PROCRIT (Epoetin alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients with Cancer Receiving Chemotherapy  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CR003196
First Received:   September 13, 2005
Last Updated:   March 17, 2008
ClinicalTrials.gov Identifier:   NCT00210600
Health Authority:   United States: Food and Drug Administration

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

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 October 03, 2008




Links to all studies - primarily for crawlers